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bioAffinity Technologies Reports $2.4 Million Revenue for Q3 2024

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bioAffinity Technologies (BIAF) reported Q3 2024 revenue of $2.4 million, with CyPath® Lung test orders showing over 1,300% growth in the first nine months of 2024 compared to full-year 2023. The company expanded its physician network by 75% compared to Q2 2024, now receiving orders from 11 states. CyPath® Lung was added to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities. The company reported a net loss of $2.0 million ($0.16 per share), an improvement from the $2.3 million loss in Q3 2023. Cash position stood at $0.8 million, with an additional $2.7 million raised through an offering in October 2024.

bioAffinity Technologies (BIAF) ha riportato un fatturato nel terzo trimestre del 2024 di 2,4 milioni di dollari, con gli ordini di test CyPath® Lung che mostrano una crescita superiore al 1.300% nei primi nove mesi del 2024 rispetto all'intero anno 2023. L'azienda ha espanso la sua rete di medici del 75% rispetto al secondo trimestre del 2024, ricevendo ora ordini da 11 stati. CyPath® Lung è stato aggiunto al Federal Supply Schedule degli Stati Uniti, fornendo accesso a 1.380 strutture sanitarie governative. L'azienda ha riportato una perdita netta di 2,0 milioni di dollari (0,16 dollari per azione), un miglioramento rispetto alla perdita di 2,3 milioni di dollari nel terzo trimestre del 2023. La posizione di liquidità si attestava a 0,8 milioni di dollari, con ulteriori 2,7 milioni di dollari raccolti tramite un'offerta nell'ottobre del 2024.

bioAffinity Technologies (BIAF) informó ingresos de 2,4 millones de dólares en el tercer trimestre de 2024, con órdenes de pruebas CyPath® Lung mostrando un crecimiento de más del 1,300% en los primeros nueves meses de 2024 en comparación con el año completo 2023. La empresa amplió su red de médicos en un 75% en comparación con el segundo trimestre de 2024, recibiendo ahora órdenes de 11 estados. CyPath® Lung fue agregado al Federal Supply Schedule de EE. UU., proporcionando acceso a 1,380 instalaciones de atención médica gubernamentales. La empresa reportó una pérdida neta de 2,0 millones de dólares (0,16 dólares por acción), una mejora respecto a la pérdida de 2,3 millones de dólares en el tercer trimestre de 2023. La posición de efectivo se situaba en 0,8 millones de dólares, con otros 2,7 millones de dólares recaudados a través de una oferta en octubre de 2024.

bioAffinity Technologies (BIAF)는 2024년 3분기 매출이 240만 달러에 달했다고 보고했으며, CyPath® Lung 테스트 주문은 2023년 전체 연도에 비해 2024년 첫 9개월 동안 1,300% 이상의 성장을 보였습니다. 이 회사는 2024년 2분기에 비해 75% 만큼 의사 네트워크를 확대하였으며, 현재 11개 주에서 주문을 받고 있습니다. CyPath® Lung은 미국 연방 조달 목록에 추가되어 1,380개 정부 의료 시설에 접근할 수 있게 되었습니다. 이 회사는 200만 달러의 순손실(주당 0.16달러)을 보고했으며, 이는 2023년 3분기에 230만 달러의 손실보다 개선된 수치입니다. 현금 보유액은 80만 달러로, 2024년 10월에 진행된 공모를 통해 추가로 270만 달러를 모집했습니다.

bioAffinity Technologies (BIAF) a annoncé un chiffre d'affaires de 2,4 millions de dollars au troisième trimestre 2024, les commandes du test CyPath® Lung affichant une croissance de plus de 1 300% au cours des neuf premiers mois de 2024 par rapport à l'année complète 2023. L'entreprise a élargi son réseau de médecins de 75% par rapport au deuxième trimestre 2024, recevant désormais des commandes de 11 États. CyPath® Lung a été ajouté au Federal Supply Schedule des États-Unis, offrant un accès à 1 380 établissements de santé gouvernementaux. L'entreprise a déclaré une perte nette de 2,0 millions de dollars (0,16 dollar par action), une amélioration par rapport à une perte de 2,3 millions de dollars au troisième trimestre 2023. La position de liquidités s'élevait à 0,8 million de dollars, avec 2,7 millions de dollars supplémentaires levés grâce à une offre en octobre 2024.

bioAffinity Technologies (BIAF) berichtete für das dritte Quartal 2024 von Einnahmen in Höhe von 2,4 Millionen Dollar, wobei die Bestellungen für den CyPath® Lung-Test im Vergleich zum Gesamtjahr 2023 ein Wachstum von über 1.300% in den ersten neun Monaten 2024 zeigten. Das Unternehmen hat sein Netzwerk von Ärzten im Vergleich zum zweiten Quartal 2024 um 75% erweitern können und erhält nun Bestellungen aus 11 Bundesstaaten. CyPath® Lung wurde dem U.S. Federal Supply Schedule hinzugefügt, was den Zugang zu 1.380 staatlichen Gesundheitseinrichtungen ermöglicht. Das Unternehmen meldete einen Nettverlust von 2,0 Millionen Dollar (0,16 Dollar pro Aktie), eine Verbesserung im Vergleich zu einem Verlust von 2,3 Millionen Dollar im dritten Quartal 2023. Die Liquiditätslage betrug 0,8 Millionen Dollar, mit zusätzlichen 2,7 Millionen Dollar, die im Oktober 2024 durch eine Platzierung gesammelt wurden.

Positive
  • Revenue growth to $2.4 million in Q3 2024 from $298,000 in Q3 2023
  • 1,300% growth rate for CyPath® Lung orders in first nine months of 2024
  • 75% increase in physician offices compared to Q2 2024
  • Reduced net loss to $2.0 million from $2.3 million year-over-year
  • Secured $2.7 million through registered direct offering in October 2024
  • Addition to Federal Supply Schedule expanding access to 1,380 government facilities
Negative
  • Cash position decreased to $0.8 million from $2.8 million at end of 2023
  • Continuing net losses of $2.0 million in Q3 2024
  • Increased selling, general and administrative expenses to $2.4 million from $2.0 million

Insights

bioAffinity Technologies shows promising growth with $2.4 million Q3 revenue, a significant increase from $298,000 in the prior year period. The 75% quarterly growth in physician offices and expansion to 11 states indicates strong market penetration. However, concerns arise from the $2.0 million net loss and declining cash position of $0.8 million, though partially addressed by a recent $2.7 million capital raise.

The addition to the Federal Supply Schedule opens access to 1,380 government healthcare facilities, representing a substantial growth opportunity with approximately 8,000 annual veteran lung cancer cases. The economic study showing potential Medicare savings of $2,773 per patient strengthens the value proposition and could drive adoption.

The CyPath® Lung test's market expansion demonstrates strong commercial traction with a 1300% order growth rate in the first nine months of 2024 versus full-year 2023. The strategic focus on Texas as a foundation for nationwide expansion, combined with increasing physician referrals and KOL endorsements, suggests a solid go-to-market strategy. The Japanese patent grant strengthens the company's intellectual property portfolio and potential international market opportunities.

The reaffirmed $9.6 million revenue forecast for the Precision Pathology subsidiary indicates management confidence in sustained growth trajectory, though execution and cash management will be important for achieving these targets.

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

SAN ANTONIO--(BUSINESS WIRE)-- 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

 

 
 

 

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

Source: bioAffinity Technologies, Inc.

FAQ

What was bioAffinity Technologies (BIAF) revenue in Q3 2024?

bioAffinity Technologies reported revenue of $2.4 million for Q3 2024.

How much did BIAF's physician network grow in Q3 2024?

The number of physician offices increased by 75% compared to Q2 2024.

What was BIAF's net loss per share in Q3 2024?

BIAF reported a net loss of $0.16 per share in Q3 2024.

How many states now order CyPath® Lung tests from BIAF?

BIAF is now receiving CyPath® Lung orders from physicians in 11 states.

bioAffinity Technologies, Inc.

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