8-K
bioAffinity Technologies, Inc. (BIAF)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 15, 2024
BIOAFFINITY
TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41463 | 46-5211056 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (I.R.S.<br> Employer<br><br> <br>Identification<br> Number) |
22211W Interstate 10
Suite1206
SanAntonio, Texas 78257
### (210)698-5334
(Address of principal executive offices and Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $.007 per share | BIAF | The<br> Nasdaq Stock Market LLC |
| Tradeable<br> Warrants to purchase Common Stock | BIAFW | The<br> Nasdaq Stock Market LLC |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item2.02. Results of Operation and Financial Condition.
On May 15, 2024, bioAffinity Technologies, Inc., a Delaware corporation (the “Registrant”), issued a press release that included financial information for its quarter ended March 31, 2024. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished with this Current Report on Form 8-K:
| Exhibit | Description |
|---|---|
| 99.1 | Press Release issued by bioAffinity Technologies, Inc. dated May 15, 2024 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date:<br> May 15, 2024 | BIOAFFINITY TECHNOLOGIES, INC. <br><br>(Registrant) | |
|---|---|---|
| By: | /s/ Maria Zannes | |
| Name: | Maria<br> Zannes | |
| Title: | President<br> and Chief Executive Officer |
Exhibit99.1
| News Release |
|---|
bioAffinityTechnologies Reports Record Q1 Revenue Driven by Accelerating Growth of CyPath^®^ Lung Sales and Increased LaboratoryVolumes
Expanded,experienced sales team more than doubles number of physician practices ordering CyPath^®^ Lung test year-to-date
Morethan 547% annualized growth rate for CyPath^®^ Lung orders in first four months of 2024 over full-year 2023, leading to 35%increase in original 2024 forecast
KOLreferrals and word-of-mouth expanding adoption of CyPath^®^ Lung outside of the beta market launch in Texas
SANANTONIO, Texas (May 15, 2024) – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended March 31, 2024.
KeyHighlights
| ● | Generated<br> record quarterly revenue of $2.4 million in the first quarter of 2024. |
|---|---|
| ● | Forecasting<br> between $9.2 and $9.6 million in 2024 revenues for wholly owned subsidiary Precision Pathology<br> Laboratory Services (PPLS), up 23% over 2023. |
| ● | Increased<br> 2024 CyPath^®^ Lung sales forecast 35% from the original forecast reported<br> in the 2023 Annual Report. |
| ● | Number<br> of physician offices ordering CyPath^®^ Lung is up 112%, more than double, since January<br> 1, 2024. |
| ● | Medicare<br> reimbursement for CyPath^®^ Lung became effective on January 1, 2024. |
| ● | More<br> than 547% annualized growth rate for CyPath^®^ Lung orders in first four months of 2024<br> over full-year 2023 with April sales showing a robust increase of 21% over the previous month. |
| ● | Referrals<br> and word-of-mouth from physicians, including key opinion leaders (KOLs), resulting in significant<br> uptake of CyPath^®^ Lung by physicians in states beyond Texas. |
| ● | Physicians<br> in Pennsylvania, New Jersey, North Carolina, Arizona, and Michigan are ordering CyPath^®^<br> Lung after hearing about it from patients and colleagues. |
| ● | Medical<br> Director of Lung Innovations Network and The Lung Center at Penn Highlands Healthcare, Dr.<br> Sandeep Bansal, joined our Medical and Scientific Advisory Board and incorporated CyPath^®^<br> Lung into his medical practice that offers comprehensive lung care to over 10,000 patients<br> in central and western Pennsylvania. |
| ● | Continued<br> to advance new product development initiatives in collaboration with the U.S Department of<br> Defense’s largest military health organization, focusing on tests that use our artificial<br> intelligence and flow cytometry platform for diagnosing COPD and companion test with bronchoscopy. |
| ● | OncoSelect<br> Therapeutics, a subsidiary of bioAffinity, was awarded a therapeutic patent in India for<br> a novel cancer treatment method using chemotherapeutic agents conjugated to porphyrins. |
| ● | Successfully<br> closed a $2.5 million registered direct offering and concurrent private placement to fund<br> continued growth. |
ManagementCommentary
“We are entering a period of accelerating growth with orders for CyPath^®^ Lung up 547% on an annualized basis in the first four months of the year compared to all of 2023,” bioAffinity President and Chief Executive Officer Maria Zannes said. “As we continue to advance our commercial strategy, moving beyond the initial test market in Texas, the unique and compelling attributes of CyPath^®^ Lung, including its AI-enhanced data analysis and non-invasive sample collection, have proven to be key differentiators in the market and are resonating with physicians and patients alike. This growing interest is leading to increased adoption by prominent medical practices and double-digit month-over-month growth in test orders.”
“CyPath^®^ Lung is positioned to set a new standard in the early detection of lung cancer – a market projected to reach $4.7 billion by 2030,” Zannes continued. “As we continue to scale our operations and enhance our offerings, our focus remains steadfast on improving patient outcomes and delivering shareholder value. With Medicare and major private insurers now providing coverage, the pathway for increased adoption and accelerated growth in usage is clear, setting the stage for substantial market penetration and revenue generation in the upcoming quarters.”
FirstQuarter Financial Results
Revenue for the first quarter of 2024 was $2.4 million, compared with $921 revenue for the prior-year period. The majority of the year-over-year increase is through the acquisition of Precision Pathology Laboratory Services. Revenue is primarily generated from patient service fees, including billing for CyPath^®^ Lung tests, with additional revenues generated from histology service fees and medical director fees.
Research and development expenses were $394,000 for the first quarter of 2024, compared with $370,000 for the comparable period in 2023. The increase was primarily due to higher compensation costs for additional research personnel and higher R&D laboratory supply costs.
Clinical development expenses were $49,000 for the first quarter of 2024, compared with $20,000 for the first quarter of 2023. The increase was primarily due to an increase in compensation costs and benefits from the addition of new clinical development personnel.
Selling, general and administrative expenses were $2.2 million for the first quarter of 2024, compared with $1.1 million for the comparable period in 2023. The increase was primarily due to acquired general and administrative costs from PPLS and an increase in personnel and services to support the launch of CyPath^®^ Lung.
Net loss for the first quarter of 2024 was $2.1 million, or $0.21 per share, compared with a net loss of $1.5 million, or $0.18 per share, for the comparable period in 2023.
Cash and cash equivalents as of March 31, 2024, were $2.5 million, compared with $2.8 million as of December 31, 2023.
AboutbioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath^®^ Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath^®^ Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-LookingStatements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding continuing to advance the Company’s commercial strategy, moving beyond the initial test market in Texas, positioning CyPath^®^ Lung to set a new standard in the early detection of lung cancer – a market projected to reach $4.7 billion by 2030, increased adoption by prominent medical practices and double-digit month-over-month growth in test orders, revised forecast of between $9.2 million and $9.6 million in 2024 revenues for wholly owned subsidiary Precision Pathology Laboratory Services, up 23% over 2023, and the increased 2024 CyPath^®^ Lung sales forecast of 35% from the original forecast reported in the 2023 Annual Report. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue to advance the Company’s commercial strategy, moving beyond the initial test market in Texas, the ability to generate revenue forecasted and to generate forecasted 2024 CyPath^®^ Lung sales, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. 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. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and 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.
Contacts
bioAffinityTechnologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
InvestorRelations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447)
Or 407-491-4498
BIAF@redchip.com
bioAffinityTechnologies, Inc.
CondensedConsolidated Balance Sheets
| December 31, 2023 | |||||
|---|---|---|---|---|---|
| ASSETS | |||||
| Current assets: | |||||
| Cash and cash equivalents | 2,453,165 | $ | 2,821,570 | ||
| Accounts and other receivables, net | 1,123,609 | 811,674 | |||
| Inventory | 9,487 | 18,484 | |||
| Prepaid expenses and other current assets | 344,900 | 321,017 | |||
| Total current assets | 3,931,161 | 3,972,745 | |||
| Non-current assets: | |||||
| Property and equipment, net | 461,209 | 458,633 | |||
| Operating lease right-of-use asset, net | 347,860 | 370,312 | |||
| Finance lease right-to-use, net | 1,069,601 | 1,165,844 | |||
| Goodwill | 1,404,486 | 1,404,486 | |||
| Intangible assets, net | 818,889 | 833,472 | |||
| Other assets | 16,060 | 16,060 | |||
| Total assets | 8,049,266 | $ | 8,221,552 | ||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable | 442,485 | $ | 604,789 | ||
| Accrued expenses | 923,810 | 1,149,811 | |||
| Unearned revenue | 30,174 | 33,058 | |||
| Operating lease liability, current portion | 96,631 | 94,708 | |||
| Finance lease liability, current portion | 372,787 | 365,463 | |||
| Notes payable, current portion | 4,686 | — | |||
| Total current liabilities | 1,870,573 | 2,247,829 | |||
| Non-current liabilities: | |||||
| Finance lease liability, net of current portion | 739,478 | 835,467 | |||
| Operating lease liability, net of current portion | 258,110 | 283,001 | |||
| Notes payable, net of current portion | 23,037 | — | |||
| Total liabilities | 2,891,198 | 3,366,297 | |||
| Commitments and contingencies | |||||
| Stockholders’ equity: | |||||
| Preferred stock, par value 0.001 per share; 20,000,000 shares authorized; no shares issued or outstanding at March 31, 2024, and December 31, 2023 | — | — | |||
| Common stock, par value 0.007 per share; 25,000,000 shares authorized; 11,214,502 and 9,394,610 issued and outstanding at March 31, 2024, and at December 31, 2023, respectively. | 78,515 | 65,762 | |||
| Additional paid-in capital | 51,744,830 | 49,393,972 | |||
| Accumulated deficit | (46,665,277 | ) | (44,604,479 | ) | |
| Total stockholders’ equity | 5,158,068 | 4,855,255 | |||
| Total liabilities and stockholders’ equity | 8,049,266 | $ | 8,221,552 |
All values are in US Dollars.
bioAffinityTechnologies, Inc.
UnauditedCondensed Consolidated Statements of Operations
| Three Months Ended <br>March 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 | 2023 | |||||
| (unaudited) | ||||||
| Net Revenue | $ | 2,406,391 | $ | 921 | ||
| Operating expenses: | ||||||
| Direct costs and expenses | 1,660,007 | 87 | ||||
| Research and development | 393,639 | 369,617 | ||||
| Clinical development | 48,960 | 19,628 | ||||
| Selling, general and administrative | 2,196,361 | 1,147,875 | ||||
| Depreciation and amortization | 149,637 | 21,684 | ||||
| Total operating expenses | 4,448,604 | 1,558,891 | ||||
| Loss from operations | (2,044,213 | ) | (1,557,970 | ) | ||
| Other income (expense): | ||||||
| Interest income | 6,127 | 38,654 | ||||
| Interest expense | (23,550 | ) | (1,655 | ) | ||
| Other income | — | — | ||||
| Other expense | 4,510 | — | ||||
| Net loss before provision for income taxes | (2,057,126 | ) | (4,919,158 | ) | ||
| Income tax expense | (3,672 | ) | (11,819 | ) | ||
| Net loss | $ | (2,060,798 | ) | $ | (1,532,790 | ) |
| Net loss per common share, basic and diluted | $ | (0.21 | ) | $ | (0.18 | ) |
| Weighted average common shares outstanding, basic and diluted | 9,915,426 | 8,433,689 |