Full Press Release Details
Technologies Reports First Quarter 2023 Financial Results
ANTONIO, Texas (May 15, 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, today reported financial results for the
three months ended March 31, 2023.
from the first quarter of 2023 and subsequent weeks included:
and Commercial Highlights
| Appointed Michael Dougherty as Chief Financial Officer. Mr. Dougherty most recently served as CFO of Amazon's Alexa commercial domains, where he was responsible for financial strategy over Alexa's multibillion-dollar investments in AI-generated customer experiences. | ||
| Engaged Havas Health & You and Trinity Life Sciences to create the branding and marketing strategy for CyPath Lung. | ||
| Continued with the initial rollout of CyPath Lung to select test markets in Texas with encouraging user feedback and survey responses. | ||
| Management rang the Nasdaq Stock Market closing bell on April 5 to commemorate the Company's IPO in September 2022. |
and Development Highlights
| Received Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled " Porphyrin Compounds and Compositions Useful for Treating Cancer " for the targeted delivery of novel cancer treatments. This patent is owned by the Company's wholly owned subsidiary OncoSelect Therapeutics and grants protection through 2037. | ||
| Expanded geographic coverage for this OncoSelect Therapeutics patent to include issuance in Hong Kong, which joins the U.S., Australia, China and Mexico, with patent applications pending in Canada, the European Union, India and Japan. | ||
| CyPath Lung clinical validation study results were published in Respiratory Research and demonstrated 92% sensitivity and 87% specificity in high-risk patients with nodules smaller than 20 millimeters or no nodules in the lung, with an area under the ROC curve of 94%. |
| The article " Porphyrin-Modified Beads for Use as Compensation Controls in Flow Cytometry" was published in the peer-reviewed Journal of Visualized Experiments (JoVE) and describes the protocol for preparing porphyrin-labeled compensation beads to optimize the ability of CyPath Lung to detect early-stage lung cancer. | ||
| Presented advancements in CyPath Lung at the Cleveland Clinic's invitation-only fourth annual " Advances in Early Lung Cancer Detection " Symposium, which brings together global leaders in the field of lung cancer, including physicians, advocates and industry, to accelerate the development and implementation of new technologies and methods for early lung cancer detection. |
first quarter results reflect our focus on positioning bioAffinity Technologies both financially and organizationally to achieve our
most important near-term objective: expanding the commercial launch of CyPath Lung into additional markets to optimize
our rollout for maximum success. Preliminary commercial results are encouraging, and with constructive initial feedback from physicians,
we're fine-tuning the CyPath Lung branding and marketing strategy. A survey of pulmonologists, internists and primary
care physicians shows that they understand the need for a noninvasive, accurate lung cancer diagnostic and are receptive to including
the test as part of their clinical decision-making for high-risk patients," bioAffinity President and Chief Executive Officer Maria
Lung is currently commercially available as a laboratory developed test through our licensee, Precision Pathology Services. The
launch of our pivotal clinical trial later this year is a critical step toward securing FDA clearance as a Class II in vitro diagnostic,
which would enable us to market directly to U.S. physicians and their patients and facilitate dialogues with payers," Ms. Zannes
Quarter Financial Results
for the first quarter of 2023 was $1,000, compared with no revenue for the prior-year period. Revenue is currently generated exclusively
from royalties from the Company's licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory
and development expenses were $370,000 for the first quarter of 2023, compared with $280,000 for the comparable period in 2022. The increase
was primarily due to higher compensation costs from adding research personnel and higher R&D equipment costs.
development expenses were $20,000 for the first quarter of 2023, compared with $53,000 for the first quarter of 2022. The decline was
primarily attributed to lower professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath
general and administrative expenses were $1.2 million for the first quarter of 2023, compared with $395,000 for the comparable period
in 2022. The increase was primarily attributed to higher consulting, legal and professional fees incurred to comply with public company
reporting requirements.
loss for the first quarter of 2023 was $1.5 million, or $0.18 per share, compared with a net loss of $1.5 million, or $0.55 per share,
for the comparable period in 2022.
and cash equivalents as of March 31, 2023, were $9.8 million, 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.
bioAffinity Technologies, Inc.
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 Texas at San Antonio. For more information, visit www.bioaffinitytech.com.
press release contains forward-looking statements, including statements regarding the anticipated use of proceeds from the Company's
offering of common shares. Forward-looking statements can be identified by words such as "believes," "expects,"
"estimates," "intends," "may," "plans," "will" and similar expressions, or
the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements
are made and predictions as to future facts and conditions. Readers of this press release are cautioned not to place undue reliance on
any forward-looking statements. The Company does not undertake any obligation to update any forward-looking statement relating to matters
discussed in this press release, except as may be required by applicable securities laws.
Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,769,088 | $ | 11,413,759 | ||||
| Accounts and other receivables, net | 11,027 | 10,489 | ||||||
| Inventory | 11,335 | 5,540 | ||||||
| Prepaid and other current assets | 441,132 | 531,899 | ||||||
| Total current assets | 10,232,582 | 11,961,687 | ||||||
| Property and equipment, net | 225,067 | 214,438 | ||||||
| Other assets | 6,920 | 6,000 | ||||||
| Total assets | $ | 10,464,569 | $ | 12,182,125 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 146,537 | $ | 345,042 | ||||
| Accrued expenses | 481,336 | 541,894 | ||||||
| Loan payable | 168,430 | 251,746 | ||||||
| Total current liabilities | 796,303 | 1,138,682 | ||||||
| Total liabilities | 796,303 | 1,138,682 | ||||||
| Commitments and contingencies (See Note 8) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at March 31, 2023, and December 31, 2022 | - | - | ||||||
| Common stock, par value $0.007 per share; 14,285,714 shares authorized; 8,463,052 issued and outstanding at March 31, 2023; and 8,381,324 shares issued and outstanding at December 31, 2022 | 59,241 | 58,669 | ||||||
| Additional paid-in capital | 47,809,283 | 47,652,242 | ||||||
| Accumulated deficit | (38,200,258 | ) | (36,667,468 | ) | ||||
| Total stockholders' equity | 9,668,266 | 11,043,443 | ||||||
| Total liabilities and stockholders' equity | $ | 10,464,569 | $ | 12,182,125 |
Condensed Consolidated Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenue | $ | 921 | $ | - | ||||
| Cost of sales | 87 | - | ||||||
| Gross profit | 834 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 369,617 | 279,848 | ||||||
| Clinical development | 19,628 | 52,503 | ||||||
| Selling, general and administrative | 1,169,559 | 394,692 | ||||||
| Total operating expenses | 1,558,804 | 727,043 | ||||||
| Loss from operations | (1,557,970 | ) | (727,043 | ) | ||||
| Other income (expense): | ||||||||
| Interest income (expense), net | 36,999 | (1,147,012 | ) | |||||
| Fair value adjustments on convertible notes payable | - | 404,194 | ||||||
| Loss before income taxes | (1,520,971 | ) | (1,469,861 | ) | ||||
| Income tax expense | 11,819 | 2,159 | ||||||
| Net loss | $ | (1,532,790 | ) | $ | (1,472,020 | ) | ||
| Net loss per common share, basic and diluted | $ | (0.18 | ) | $ | (0.55 | ) | ||
| Weighted average common shares outstanding | 8,433,689 | 2,681,221 |