bioAffinity Technologies Reports $2.4 Million Revenue for Q3 2024
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.
- 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
- 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
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
The CyPath® Lung test's market expansion demonstrates strong commercial traction with a
The reaffirmed
Expanded CyPath® Lung test sales to physicians in
Number of physician offices signed increased
Reaffirmed
Key Highlights
-
Generated quarterly revenue of
in the third quarter of 2024.$2.4 million -
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 fromPennsylvania ,New Jersey ,North Carolina ,Arizona ,Michigan ,California , andOhio , physicians inAlabama ,Louisiana andIllinois 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
per patient for total cost savings of$2,773 in 2022.$379 million - 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
registered direct offering and concurrent private placement to fund continued growth.$2.7 million
Management Commentary
“We are pleased with the continued progress we achieved in the third quarter, highlighted by a
“Our focus remains on expanding our operations and strengthening our foothold in this rapidly growing market,” Zannes continued. “Our strategic approach in
Third Quarter Financial Results
Revenue for the third quarter of 2024 was
Research and development expenses were
Clinical development expenses were
Selling, general and administrative expenses were
Net loss for the third quarter of 2024 was
Cash and cash equivalents as of September 30, 2024, were
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.
|
||||||||
|
|
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 |
|
|
— |
|
|
|
— |
|
Common stock, par value |
|
|
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.
|
||||||||||||||||
|
|
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
Source: bioAffinity Technologies, Inc.
FAQ
What was bioAffinity Technologies (BIAF) revenue in Q3 2024?
How much did BIAF's physician network grow in Q3 2024?
What was BIAF's net loss per share in Q3 2024?