Biocept Reports Second Quarter 2023 Financial Results
- Biocept is diligently working towards establishing its proprietary cerebrospinal fluid assay CNSide™ as standard of care, which could broaden physician adoption and support reimbursement. The company is also making progress in the FORESEE clinical trial, with patient enrollment passing the midpoint and plans to provide further evidence of CNSide’s clinical utility through publication in peer-reviewed medical journals.
- Biocept reported cash of $6.6 million as of June 30, 2023, and received net cash proceeds of approximately $3.6 million from an underwritten public offering in May 2023.
- Net revenues for the second quarter of 2023 were $0.6 million, compared with $5.8 million for the second quarter of 2022, with the decline due to lower RT-PCR COVID-19 testing volume. The company also reported a net loss of $3.6 million for the second quarter of 2023, compared with a net loss of $10.0 million for the second quarter of 2022.
“Biocept’s primary focus is establishing our proprietary cerebrospinal fluid assay CNSide™ as standard of care. We continue to diligently work towards submission to the National Comprehensive Cancer Network® (NCCN®) for consideration to include CNSide in their standard-of-care guidelines. We believe securing this status will broaden physician adoption and support reimbursement that reflects our test’s value in clinical decision-making,” said Antonino Morales, Biocept President and CEO. “Our ongoing FORESEE clinical trial is powered to generate data in support of this goal by assessing CNSide’s impact on physicians’ treatment decisions. I’m exceptionally pleased that patient enrollment in FORESEE has passed the midpoint, with four clinical sites open around the country for patient recruitment and several additional medical centers expected to join in the coming weeks.
“We plan to provide further evidence of CNSide’s clinical utility through publication in peer-reviewed medical journals. We have submitted a manuscript with a description of our assay and its features, validation from pilot studies and compelling case studies showing actual use in patient management. Four additional manuscripts are being prepared in collaboration with leading neuro-oncologists for submission to scientific journals, including several documenting their clinical experiences with CNSide in their practices,” Mr. Morales continued.
“We right sized our business to align with our primary focus, which is helping to extend our cash runway. Progressing towards standard of care, completing the FORESEE clinical trial, and reducing expenses are key to Biocept becoming a self-sustaining business,” Mr. Morales added.
Earlier today Biocept announced that Priya U. Kumthekar, MD, a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist at Northwestern University, and David Piccioni, MD, PhD, Director of Neuro-Oncology at University of
Biocept intends to host a business update call later in August to present a progress report on the FORESEE trial and discuss other recent developments. Details of the call will be announced in a press release.
Second Quarter Financial Results
Net revenues for the second quarter of 2023 were
Cost of revenues for the second quarter of 2023 was
Research and development (R&D) expenses for the second quarter of 2023 were
General and administrative (G&A) expenses for the second quarter of 2023 were
Sales and marketing expenses for the second quarter of 2023 were
Non-cash change in the fair value of warrant liability for the second quarter of 2023 was
Net loss attributable to common stockholders for the second quarter of 2023 was
Six Month Financial Results
Net revenues for the first half of 2023 were
Operating expenses for the first half of 2023 were
Net loss attributable to common stockholders for the first half of 2023 was
Biocept reported cash of
About the FORESEE Clinical Trial
The multi-center, prospective FORESEE clinical trial is a longitudinal therapy response monitoring study in subjects with leptomeningeal metastases (LM) using CNSide™ (CSF Tumor Cells) compared to standard of care (CSF cytology, clinical evaluation, and imaging). The goal of the FORESEE trial is to evaluate the performance of CNSide in monitoring the response of LM to treatment and to assess the impact of CNSide on treatment decisions made by physicians. The trial is enrolling up to 40 patients with breast or non-small cell lung cancer (NSCLC) who have suspected or confirmed LM. Standard of care methods to diagnose or assess the treatment response of LM have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide is a Laboratory Developed Test (LDT) that is used commercially at the physician’s discretion in Biocept’s CLIA-certified, CAP-accredited laboratory.
About Biocept
Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample.
Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like "will," "expect," “goal,” “objective,” "believe" or "intend" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements regarding FORESEE’s potential to generate evidence of CNSide’s clinical utility to support adoption into clinical care guidelines and broaden physician adoption and support reimbursements, our expectation that several additional medical centers will join the FORESEE clinical trial in the coming weeks, our plan to provide further evidence of CNSide’s clinical utility through publication in peer-reviewed medical journals, additional manuscripts to be submitted for peer review, our cash runway, and other statements that are not historical fact, are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risks and uncertainties, including that the results of the FORESEE clinical trial may not support the inclusion of CNSide in clinical care guidelines; Medicare and private payors may not provide coverage and reimbursement or may breach, rescind or modify their contracts or reimbursement policies or delay payments; risks related to our need for additional capital; and the risk that our products and services may not perform as expected. These and other factors are described in greater detail under the "Risk Factors" heading in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the Securities and Exchange Commission (SEC) on May 10, 2023, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, being filed with the SEC today. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC at http://www.sec.gov/.
Biocept, Inc. |
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Condensed Balance Sheets |
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(In thousands, except share and per share data) |
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|
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|
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June 30, |
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December 31, |
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|
|
2023 |
|
2022 |
||||
Assets |
|
(unaudited) |
|
|
||||
Current assets: |
|
|
|
|
||||
Cash |
|
$ |
6,633 |
|
|
$ |
12,897 |
|
Accounts receivable |
|
|
800 |
|
|
|
2,151 |
|
Inventories, net |
|
|
551 |
|
|
|
757 |
|
Prepaid expenses and other current assets |
|
|
876 |
|
|
|
538 |
|
Total current assets |
|
|
8,860 |
|
|
|
16,343 |
|
Fixed assets, net |
|
|
2,395 |
|
|
|
2,572 |
|
Lease right-of-use asset - operating |
|
|
8,190 |
|
|
|
8,486 |
|
Lease right-of-use assets - finance |
|
|
2,272 |
|
|
|
3,086 |
|
Other non-current assets |
|
|
386 |
|
|
|
386 |
|
Total assets |
|
$ |
22,103 |
|
|
$ |
30,873 |
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
1,467 |
|
|
$ |
1,523 |
|
Accrued liabilities |
|
|
1,529 |
|
|
|
2,249 |
|
Current portion of lease liability - operating |
|
|
565 |
|
|
|
518 |
|
Current portion of lease liabilities - finance |
|
|
815 |
|
|
|
1,099 |
|
Financed insurance premiums |
|
|
526 |
|
|
|
117 |
|
Total current liabilities |
|
|
4,902 |
|
|
|
5,506 |
|
Non-current portion of lease liability - operating |
|
|
8,849 |
|
|
|
9,175 |
|
Non-current portion of lease liabilities - finance |
|
|
836 |
|
|
|
1,200 |
|
Payor liability |
|
|
6,149 |
|
|
|
6,132 |
|
Warrant liability |
|
|
1,077 |
|
|
|
— |
|
Total liabilities |
|
|
21,813 |
|
|
|
22,013 |
|
Commitments and contingencies |
|
|
|
|
||||
Stockholders’ equity: |
|
|
|
|
||||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
309,503 |
|
|
|
307,298 |
|
Accumulated deficit |
|
|
(309,213 |
) |
|
|
(298,438 |
) |
Total stockholders’ equity |
|
|
290 |
|
|
|
8,860 |
|
Total liabilities and stockholders’ equity |
|
$ |
22,103 |
|
|
$ |
30,873 |
|
Biocept, Inc. |
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Condensed Statements of Operations |
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(In thousands, except shares and per share data) |
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(Unaudited) |
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|
|
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For the Three Months Ended
|
|
For the Six Months Ended
|
||||||||||||
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
Net revenues |
|
$ |
589 |
|
|
$ |
5,819 |
|
|
$ |
1,262 |
|
|
$ |
25,763 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
||||||||
Cost of revenues |
|
|
2,550 |
|
|
|
8,023 |
|
|
|
5,578 |
|
|
|
18,357 |
|
Research and development expenses |
|
|
409 |
|
|
|
1,729 |
|
|
|
1,449 |
|
|
|
3,574 |
|
General and administrative expenses |
|
|
3,494 |
|
|
|
4,300 |
|
|
|
6,482 |
|
|
|
10,556 |
|
Sales and marketing expenses |
|
|
250 |
|
|
|
1,656 |
|
|
|
965 |
|
|
|
5,314 |
|
Total costs and expenses |
|
|
6,703 |
|
|
|
15,708 |
|
|
|
14,474 |
|
|
|
37,801 |
|
Loss from operations |
|
|
(6,114 |
) |
|
|
(9,889 |
) |
|
|
(13,212 |
) |
|
|
(12,038 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
||||||||
Interest expense, net |
|
|
(50 |
) |
|
|
(155 |
) |
|
|
(96 |
) |
|
|
(217 |
) |
Other income, net |
|
|
91 |
|
|
|
— |
|
|
|
91 |
|
|
|
— |
|
Change in fair value of warrant liability |
|
|
2,442 |
|
|
|
— |
|
|
|
2,442 |
|
|
|
— |
|
Total other income (expense): |
|
|
2,483 |
|
|
|
(155 |
) |
|
|
2,437 |
|
|
|
(217 |
) |
Loss before income taxes |
|
|
(3,631 |
) |
|
|
(10,044 |
) |
|
|
(10,775 |
) |
|
|
(12,255 |
) |
Income tax expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
|
(3,631 |
) |
|
|
(10,044 |
) |
|
|
(10,775 |
) |
|
|
(12,255 |
) |
Net loss attributable to common stockholders |
|
$ |
(3,631 |
) |
|
$ |
(10,044 |
) |
|
$ |
(10,775 |
) |
|
$ |
(12,255 |
) |
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders: |
|
|
|
|
|
|
|
|
||||||||
Basic |
|
|
1,036,529 |
|
|
|
563,528 |
|
|
|
813,180 |
|
|
|
562,561 |
|
Diluted |
|
|
1,036,529 |
|
|
|
563,528 |
|
|
|
813,180 |
|
|
|
562,561 |
|
Net loss per common share: |
|
|
|
|
|
|
|
|
||||||||
Basic |
|
$ |
(3.50 |
) |
|
$ |
(17.82 |
) |
|
$ |
(13.25 |
) |
|
$ |
(21.78 |
) |
Diluted |
|
$ |
(3.50 |
) |
|
$ |
(17.82 |
) |
|
$ |
(13.25 |
) |
|
$ |
(21.78 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230814999814/en/
Investor & Media Contact:
LHA Investor Relations
Jody Cain
Jcain@lhai.com
(310) 691-7100
Source: Biocept, Inc.
FAQ
What are Biocept's net revenues for the second quarter of 2023?
What is Biocept's primary focus?
What is the status of Biocept's FORESEE clinical trial?
What was Biocept's net loss for the second quarter of 2023?
