BIAF bioAffinity Technologies Inc

Expanded CyPath® Lung test sales to physicians in Illinois, Alabama, and Louisiana; now receiving orders from physicians in 11 states

Number of physician offices signed increased 75% over Q2 2024

Reaffirmed $9.6 million 2024 revenue forecast for wholly owned Precision Pathology subsidiary

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 September 30, 2024.

Key Highlights

• Generated quarterly revenue of $2.4 million in the third quarter of 2024.
• More than 1,300% growth rate for CyPath® Lung orders in first nine months of 2024 over full-year 2023.
• Number of physician offices signed increased by 75% compared to the second quarter of 2024, setting the stage for acceleration of CyPath® Lung sales in the quarters ahead.
• In October 2024, CyPath® Lung was added to the U.S. Federal Supply Schedule (FSS), a procurement system that provides the Veterans Health Administration and the Military Health System streamlined access to state-of-the-art healthcare products and services. Under the FSS contract, Veterans at high risk for lung cancer will have easy access to CyPath® Lung through 1,380 government health care facilities. Approximately 8,000 Veterans are treated for lung cancer annually, according to the VA.
• Referrals and word-of-mouth from physicians, including key opinion leaders (KOLs), continues to be a key driver for expanding CyPath® Lung in states beyond Texas; now receiving CyPath® Lung orders from physicians in 11 states, up from eight in the second quarter of 2024. In addition to previously reported orders from Pennsylvania, New Jersey, North Carolina, Arizona, Michigan, California, and Ohio, physicians in Alabama, Louisiana and Illinois have also begun ordering CyPath® Lung tests.
• Added new sales representative to target increasing opportunities in Texas.
• Continued to advance new product development initiatives in collaboration with Brooke Army Medical Center, the U.S Department of Defense’s largest military health organization, focusing on tests that use the Company’s artificial intelligence and flow cytometry platform for diagnosing COPD and a companion test with bronchoscopy.
• Economic study published in Journal of Health Economics and Outcomes Research, a peer-reviewed journal, concludes that adding CyPath® Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient for total cost savings of $379 million in 2022.
• Awarded a Certificate of Grant of Patent from the Japan Patent Office for the Company’s unique method using flow cytometry to predict the likelihood of lung disease, including the CyPath® Lung diagnostic test for early-stage lung cancer.
• Appointed William Bauta, Ph.D., as Chief Science Officer following the retirement of Vivienne I. Rebel, M.D., Ph.D. Dr. Bauta joined bioAffinity in 2016 as Senior Vice President. Previously, he was Associate Director of science at Genzyme.
• Successfully closed a $2.7 million registered direct offering and concurrent private placement to fund continued growth.

Management Commentary

“We are pleased with the continued progress we achieved in the third quarter, highlighted by a 75% growth in the number of physician offices signing on to offer CyPath® Lung. This significant expansion not only reflects the increasing recognition of our test’s value in early lung cancer detection but also lays a strong foundation for accelerating sales growth in the coming quarters,” bioAffinity President and Chief Executive Officer Maria Zannes said. “With CyPath® Lung now being used in 11 states and its recent addition to the U.S. Federal Supply Schedule, we are making meaningful strides in broadening access to this innovative diagnostic tool.

“Our focus remains on expanding our operations and strengthening our foothold in this rapidly growing market,” Zannes continued. “Our strategic approach in Texas has resulted in a robust sales and support infrastructure that has us well-equipped to meet rising demand and accelerate our nationwide growth. As we look toward the future, we are confident that these efforts will not only fuel our success but also advance our mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics.”

Third Quarter Financial Results

Revenue for the third quarter of 2024 was $2.4 million, compared with $298,000 revenue for the prior-year period. The majority of the year-over-year increase is through the acquisition of Precision Pathology Laboratory Services, LLC (PPLS). 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 $274,000 for the third quarter of 2024, compared with $330,000 for the comparable period in 2023. The decrease was primarily due to higher R&D laboratory supply and equipment costs following the acquisition of PPLS in the prior year period.

Clinical development expenses were $94,000 for the third quarter of 2024, compared with $106,000 for the third quarter of 2023. The decrease was primarily attributable to higher professional fees in the prior year period related to evaluating the clinical strategy for the Company’s Food and Drug Administration (FDA) pivotal CyPath® Lung clinical trial.

Selling, general and administrative expenses were $2.4 million for the third quarter of 2024, compared with $2.0 million for the comparable period in 2023. The increase was primarily attributed to an increase in sales personnel and services to support the launch of CyPath® Lung, together with acquired general and administrative costs from PPLS.

Net loss for the third quarter of 2024 was $2.0 million, or $0.16 per share, a $0.3 million improvement from a net loss of $2.3 million, or $0.26 per share, for the comparable period in 2023.

Cash and cash equivalents as of September 30, 2024, were $0.8 million, compared with $2.8 million as of December 31, 2023. Subsequent to the end of the third quarter of 2024, bioAffinity Technologies raised aggregate gross proceeds of $2.7 million in a registered direct offering and concurrent private placement closed on October 21, 2024.

About bioAffinity 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 wholly owned subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.

Forward-Looking Statements

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 accelerating sales growth in the coming quarters; broadening access to CyPath® Lung; expanding the Company’s operations and strengthening its foothold in the rapidly growing market; the Company’s ability to meet rising demand and accelerate its nationwide growth; the Company’s ability to advance its mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics; and the ability of the Company to address the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. 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 accelerate sales growth and expand its operations; the Company’s ability to meet rising demand and accelerate its nationwide growth; the Company’s ability to advance its mission to enhance patient outcomes through groundbreaking, noninvasive cancer diagnostics; the ability of the Company to address the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments, 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.

     

bioAffinity Technologies, Inc. Condensed Consolidated Balance Sheets 

 

 

 

September 30,

2024

 

December 31,

2023

 

 

(unaudited)

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

756,580

 

 

$

2,821,570

 

Accounts and other receivables, net

 

 

1,327,168

 

 

 

811,674

 

Inventory

 

 

25,363

 

 

 

18,484

 

Prepaid expenses and other current assets

 

 

440,027

 

 

 

321,017

 

Total current assets

 

 

2,549,138

 

 

 

3,972,745

 

 

 

 

 

 

 

 

Non-current assets:

 

 

 

 

 

 

Property and equipment, net

 

 

418,190

 

 

 

458,633

 

Operating lease right-of-use asset, net

 

 

493,687

 

 

 

370,312

 

Finance lease right-of-use asset, net

 

 

877,115

 

 

 

1,165,844

 

Goodwill

 

 

1,404,486

 

 

 

1,404,486

 

Intangible assets, net

 

 

789,722

 

 

 

833,472

 

Other assets

 

 

19,676

 

 

 

16,060

 

 

 

 

 

 

 

 

Total assets

 

$

6,552,014

 

 

$

8,221,552

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

782,937

 

 

$

604,789

 

Accrued expenses

 

 

904,252

 

 

 

1,149,811

 

Unearned revenue

 

 

24,404

 

 

 

33,058

 

Operating lease liability, current portion

 

 

124,710

 

 

 

94,708

 

Finance lease liability, current portion

 

 

387,780

 

 

 

365,463

 

Notes payable, current portion

 

 

267,081

 

 

 

—

 

Total current liabilities

 

 

2,491,164

 

 

 

2,247,829

 

 

 

 

 

 

 

 

Non-current liabilities:

 

 

 

 

 

 

Finance lease liability, net of current portion

 

 

543,007

 

 

 

835,467

 

Operating lease liability, net of current portion

 

 

375,139

 

 

 

283,001

 

Notes payable, net of current portion

 

 

21,679

 

 

 

—

 

 

 

 

 

 

 

 

Total liabilities

 

 

3,430,989

 

 

 

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 September 30, 2024, and December 31, 2023

 

 

—

 

 

 

—

 

Common stock, par value $0.007 per share; 100,000,000 shares authorized; 13,424,648 and 9,394,610 issued and outstanding at September 30, 2024, and December 31, 2023, respectively

 

 

90,064

 

 

 

65,762

 

Additional paid-in capital

 

 

53,708,374

 

 

 

49,393,972

 

Accumulated deficit

 

 

(50,677,413

)

 

 

(44,604,479

)

 

 

 

 

 

 

 

Total stockholders’ equity

 

 

3,121,025

 

 

 

4,855,255

 

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

6,552,014

 

 

$

8,221,552

 

       

bioAffinity Technologies, Inc. Unaudited Condensed Consolidated Statements of Operations 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2024

 

2023

 

2024

 

2023

 

 

 

 

 

 

 

 

 

Net Revenue

 

$

2,350,386

 

 

$

298,484

 

 

$

7,154,429

 

 

$

319,143

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Direct costs and expenses

 

 

1,440,158

 

 

 

74,704

 

 

 

4,421,309

 

 

 

76,025

 

Research and development

 

 

274,497

 

 

 

330,376

 

 

 

1,070,569

 

 

 

1,035,118

 

Clinical development

 

 

93,705

 

 

 

106,422

 

 

 

194,127

 

 

 

161,310

 

Selling, general and administrative

 

 

2,364,592

 

 

 

2,023,917

 

 

 

7,023,311

 

 

 

4,576,708

 

Depreciation and amortization

 

 

151,298

 

 

 

57,569

 

 

 

452,005

 

 

 

100,805

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses

 

 

4,324,250

 

 

 

2,592,988

 

 

 

13,161,321

 

 

 

5,949,966

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(1,973,864

)

 

 

(2,294,504

)

 

 

(6,006,892

)

 

 

(5,630,823

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,228

 

 

 

27,193

 

 

 

13,541

 

 

 

109,971

 

Interest expense

 

 

(21,631

)

 

 

(8,785

)

 

 

(67,430

)

 

 

(11,801

)

Other income

 

 

9,683

 

 

 

4,606

 

 

 

9,683

 

 

 

4,606

 

Other expense

 

 

(14,697

)

 

 

(17,100

)

 

 

(10,186

)

 

 

(17,100

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Total other income (expense)

 

 

(24,417

)

 

 

5,914

 

 

 

(54,392

)

 

 

85,676

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss before provision for income tax expense

 

 

(1,998,281

)

 

 

(2,288,590

)

 

 

(6,061,284

)

 

 

(5,545,147

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Income tax expense

 

 

2,559

 

 

 

2,294

 

 

 

11,650

 

 

 

18,700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(2,000,840

)

 

$

(2,290,884

)

 

$

(6,072,934

)

 

$

(5,563,847

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per common share, basic and diluted

 

$

(0.16

)

 

$

(0.26

)

 

$

(0.54

)

 

$

(0.65

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding

 

 

12,391,867

 

 

 

8,696,554

 

 

 

11,237,324

 

 

 

8,551,154

 

   

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20241114473397/en/

bioAffinity Technologies Julie Anne Overton Director of Communications jao@bioaffinitytech.com

Investor Relations Dave Gentry RedChip Companies Inc. 1-800-RED-CHIP (733-2447) or 407-491-4498 BIAF@redchip.com