Tillkännagivande • Oct 26
Biocept, Inc.(OTCPK:BIOC.Q) dropped from NASDAQ Composite Index Biocept, Inc. will be removed from NASDAQ Composite Index. Tillkännagivande • Oct 21
Biocept's Securities To Be Delisted from Nasdaq On October 16, 2023, Biocept, Inc. received a letter (“Delisting Notice”) from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the Staff had determined that the Company’s securities will be delisted from Nasdaq pursuant to Nasdaq Listing Rules 5101, 5110(b) and IM-5101-1, in connection with the filing of a voluntary case under Chapter 7 of Title 11 of the United States Bankruptcy Code, 11 U.S.C. §§ 101 et seq. (the “Code”) in the United States Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) on October 13, 2023. Pursuant to the Delisting Notice, Nasdaq’s decision was based on the following factors: (i) The public interest concerns raised by the filing; (ii) concerns regarding the residual equity interest of the existing listed securities holders; and (iii) concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq. Specifically, on May 17, 2023, Staff also notified the Company that it failed to maintain a minimum of $2,500,000 in stockholders’ equity required for continued listing pursuant to Listing Rule 5550(b)(1), which deficiency serves as an additional and separate basis for delisting. The Staff letter indicates that the trading of the Company’s common stock and warrants will be suspended at the opening of business on October 25, 2023, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company’s securities from listing and registration on Nasdaq. The Company does not intend to appeal the determination and, therefore, it is expected that its Common Stock will be delisted, which would not affect any actions it may take in bankruptcy. Trading of the Common Stock will be suspended by Nasdaq at the opening of business on October 25, 2023. Tillkännagivande • Oct 19
Biocept, Inc.(NasdaqCM:BIOC) dropped from S&P TMI Index Biocept, Inc.(NasdaqCM:BIOC) dropped from S&P TMI Index Tillkännagivande • Sep 22
Biocept, Inc. Announces the Full Enrollment of 40 Subjects with Breast or Non-Small Cell Lung Cancer Biocept, Inc. announced the full enrollment of 40 subjects with breast or non-small cell lung cancer (NSCLC) who have suspicious or confirmed leptomeningeal metastases (LM) in the feasibility phase of its prospective FORESEE clinical trial (NCT0414123). This trial is evaluating the performance of Biocept's proprietary CNSide assay in monitoring the response to therapy of LM, a cancer in the membranes that surround the brain and spinal cord, and assessing its impact on treatment decisions made by physicians. The FORESEE trial is specifically designed to measure the impact of CNSide on physicians' clinical decisions to generate the data needed to help reach this goal. FORESEE is a two-part prospective clinical trial designed to follow subjects and collect data from each enrollee at four key time points in their treatment, as well as to compare CNSide cell detection in the cerebrospinal fluid to that of conventional cytology. CNSide has notable advantages over current standards of care, such as cytology, clinical evaluation and MRI, which have limited sensitivity and specificity. Biocept expects to have results from the feasibility phase of the FORESEE trial in the first half of 2024 and to then begin enrolling between 40 and 100 subjects in the trial's validation phase. Enrollment is currently open at four clinical sites with two additional sites expected to join the FORESEE trial in The near term. Tillkännagivande • May 16
Biocept Expects to Receive Non-Compliance Notice Form Nasdaq As reported in Biocept, Inc.'s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the Securities and Exchange Commission on May 10, 2023, the Company's stockholders' equity as of March 31, 2023 was $2.4 million. As a result, the Company does not satisfy one of The Nasdaq Capital Market continued listing requirements set in Nasdaq Stock Market Rule 5550(b) (the Rule"). The Company expects to receive a formal notice (the Notice") from The Nasdaq Stock Market LLC (Nasdaq") on or about May 15, 2023 to formally notify the Company of non-compliance with the Rule. The Company discussed the noncompliance with the Rule with Nasdaq on May 12, 2023. Pursuant to the Notice and Nasdaq rules, the Company will have 45 calendar days after receipt of the Notice to submit a plan to regain compliance with the Rule. If the plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice for the Company to provide evidence of compliance. There can be no assurance that the Company will be able to regain compliance with the Rule. Breakeven Date Change • Apr 27
No longer forecast to breakeven The 2 analysts covering Biocept no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$5.04m in 2025. New consensus forecast suggests the company will make a loss of US$9.00m in 2025. Reported Earnings • Apr 18
Full year 2022 earnings released: US$1.89 loss per share (vs US$0.19 loss in FY 2021) Full year 2022 results: US$1.89 loss per share (further deteriorated from US$0.19 loss in FY 2021). Revenue: US$25.9m (down 58% from FY 2021). Net loss: US$32.1m (loss widened US$29.3m from FY 2021). Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has fallen by 57% per year, which means it is significantly lagging earnings. Breakeven Date Change • Apr 18
No longer forecast to breakeven The 2 analysts covering Biocept no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$5.04m in 2025. New consensus forecast suggests the company will make a loss of US$9.00m in 2025. Breakeven Date Change • Feb 14
Forecast to breakeven in 2025 The 2 analysts covering Biocept expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$5.04m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Tillkännagivande • Nov 19
Biocept, Inc. Appoints Quyen Dao-Haddock to the Board of Directors Biocept, Inc. announced the appointment of Quyen Dao-Haddock to its Board of Directors, effective immediately, increasing Board membership to eight. Ms. Dao-Haddock is a certified public accountant (CPA) with more than 20 years of financial and accounting experience. She will serve on Biocept’s Audit Committee. Ms. Dao-Haddock serves as controller of IQHQ, Inc., with responsibility for scaling the accounting and finance department and establishing and implementing comprehensive accounting policies. She previously was Chief Accounting Officer of Presidio Property Trust, Inc., where she was responsible for all financial and accounting operations of this REIT with more than $30 million in annual revenues and $200 million in assets. Earlier she was Corporate Controller of American Assets Trust, Inc. and Controller at Pacific Corporate Group, LLC. She began her career as an Audit Manager at KPMG LLP. Ms. Dao-Haddock serves on the Audit & Compliance Committee of Sharp HealthCare. She received a BS in Business Administration, Accounting from San Diego State University. Tillkännagivande • Nov 15
Biocept, Inc. announced delayed 10-Q filing On 11/14/2022, Biocept, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • Oct 20
Biocept Receives Non-Compliance Letter from Nasdaq On October 18, 2022, Biocept, Inc. (the Company") received a notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") advising the Company that for the 30 consecutive trading days preceding the Notice, the bid price of the Company's common stock had closed below the $1.00 per share minimum required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). The Notice has no effect on the listing of the Company's common stock at this time, and the Company's common stock continues to trade on The Nasdaq Capital Market under the symbol BIOC." Under Nasdaq Listing Rule 5810(c)(3)(A), if during the 180 calendar day period following the date of the Notice (the Compliance Period") the closing bid price of the Company's common stock is at or above $1.00 for a minimum of 10 consecutive business days, the Company will regain compliance with the Minimum Bid Price Requirement and its common stock will continue to be eligible for listing on The Nasdaq Capital Market absent noncompliance with any other requirement for continued listing. If the Company does not regain compliance by the end of the Compliance Period, the Company may be eligible for an additional 180 calendar day compliance period (the Additional Compliance Period") if, as of the end of the Compliance Period, the Company meets the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the Minimum Bid Price Requirement, and the Company provides written notice of its intention to cure the deficiency during the Additional Compliance Period, by effecting a reverse stock split, if necessary. If the Company is not eligible for the Additional Compliance Period or it appears to the Staff of the Nasdaq Stock Market (the Staff") that the Company will not be able to cure the deficiency, the Staff will provide written notice to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff's delisting determination to a Nasdaq Hearing Panel. In response to the Notice, the Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement. Tillkännagivande • Oct 18
Biocept, Inc. Expands Commercial Offering of Cnside(Tm) Assay to Most Cancers That Metastasize to the Central Nervous System Biocept, Inc. announced the expanded commercial availability of CNSide for patients with metastatic melanoma. Previously validated for lung, breast, and all other carcinomas, Biocept's CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS). The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics. This assay represents a significant development in the field of neuro-oncology related diagnostics. It is believed to be the first CLIA-validated assay designed for the quantitative identification of melanoma cells in CSF. Melanoma is the third most common tumor type involved in CNS metastasis, with more than 60% of Stage IV melanoma patients developing CNS metastasis from their disease. Overall survival expectancy is low and patient management can be challenging due in part to diagnostic limitations. CNSide addresses a high unmet clinical need, as current standard of care approaches--CSF cytology and MRI imaging--have limited sensitivity for detecting CNS metastasis and are not adequate to assess the response to therapy. CNSide can also help identify molecular biomarkers considered targets for novel therapy approaches. Combined, these features help clinicians answer three key questions for patients with CNS metastasis: Is there t umor? Is there a target for treatment? Is there a trend or favorable response to treatment?. Tillkännagivande • Aug 23
Biocept Announces Receipt of Deficiency Notice from Nasdaq Regarding Requirement to Timely Quarterly Report on Form 10-Q Biocept, Inc. announced that it received a notice (the ‘Notice’) on August 17, 2022 from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) advising Biocept that it was not in compliance with Nasdaq’s continued listing requirements under the Nasdaq Listing Rule 5250(c)(1) (the ‘Rule’) as a result of its failure to file its Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 (the ‘Form 10-Q’) in a timely manner. The Rule requires listed companies to timely file all required periodic reports with the Securities and Exchange Commission (the ‘SEC’). Biocept previously reported in its Form 12b-25 filed with the SEC on August 16, 2022 that Biocept was unable to file the Form 10-Q within the prescribed time period as a result of ongoing accounting review, including the analysis of previously reported material weaknesses and matters related to the U.S. Health Resources Services Administration and its funding for reimbursement of COVID-19 testing services performed by Biocept. Under Nasdaq rules, Biocept has 60 calendar days from the receipt of the Notice, or until October 17, 2022, to submit a plan to regain compliance with the Rule. If Nasdaq accepts Biocept’s plan, Nasdaq may grant Biocept up to 180 calendar days from the due date of the Form 10-Q, or until February 13, 2023, to regain compliance. In response to the Notice, Biocept intends to file the Form 10-Q as promptly as possible in order to regain compliance with the Rule. If Biocept does not submit the Form 10-Q by October 17, 2022, it intends to timely submit a plan to regain compliance with the Rule. Tillkännagivande • Aug 17
Biocept, Inc. announced delayed 10-Q filing On 08/16/2022, Biocept, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 17
Biocept, Inc. announced delayed 10-Q filing On 05/16/2022, Biocept, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Tillkännagivande • May 03
Biocept, Inc., Annual General Meeting, Jun 10, 2022 Biocept, Inc., Annual General Meeting, Jun 10, 2022, at 13:30 Pacific Standard Time. Agenda: To consider the election of one Class III director for a three-year term to expire at the 2025 annual meeting of stockholders; to approve an amendment to 2013 Amended and Restated Equity Incentive Plan, as amended, to increase the number of shares authorized for issuance under such plan by 3,000,000 shares; to approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in the Proxy Statement accompanying this notice; and to consider other matter. Tillkännagivande • Apr 03
Biocept, Inc. announced delayed annual 10-K filing On 04/01/2022, Biocept, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Valuation Update With 7 Day Price Move • Mar 22
Investor sentiment improved over the past week After last week's 15% share price gain to €1.95, the stock trades at a trailing P/E ratio of 17.3x. Average forward P/E is 39x in the Biotechs industry in Europe. Total loss to shareholders of 83% over the past three years. Tillkännagivande • Mar 10
Biocept, Inc. Appoints Philippe Marchand as Chief Operating Officer Biocept, Inc. has appointed Philippe Marchand, Ph.D., to the position of Chief Operating Officer, effective today. Dr. Marchand will be responsible for advancing the company’s strategic and operational objectives, including all laboratory operations of its CNSide cerebrospinal fluid assay, which helps physicians better detect and manage treatment of patients with metastatic cancers involving the central nervous system. Dr. Marchand is a veteran biotechnology executive and scientist with a proven track record in transitioning concepts to implementation and commercialization. Most recently, Dr. Marchand was the Chief Operating Officer of Biosplice Therapeutics, aiding in the development of first-in-class small-molecule therapeutics. Previously, he was the Chief Information Officer of Genoptix, where he oversaw the creation of the company’s diagnostics laboratory, and was instrumental in its IPO and subsequent acquisition by Novartis. Following the acquisition, he assumed responsibilities for global IT operations for Novartis Oncology. Valuation Update With 7 Day Price Move • Feb 24
Investor sentiment deteriorated over the past week After last week's 17% share price decline to €1.95, the stock trades at a trailing P/E ratio of 17.8x. Average forward P/E is 33x in the Biotechs industry in Europe. Total loss to shareholders of 79% over the past three years. Reported Earnings • Feb 17
Third quarter 2021 earnings: EPS in line with analyst expectations despite revenue beat Third quarter 2021 results: US$0.041 loss per share (up from US$0.37 loss in 3Q 2020). Revenue: US$17.5m (up 165% from 3Q 2020). Net loss: US$624.7k (loss narrowed 87% from 3Q 2020). Revenue exceeded analyst estimates by 8.8%. Over the next year, revenue is expected to shrink by 37% compared to a 59% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 127% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. Tillkännagivande • Feb 11
Biocept Names Darrell Taylor as Senior Vice President, General Counsel and Chief Compliance Officer Biocept, Inc. has appointed Darrell Taylor as Senior Vice President, General Counsel and Chief Compliance Officer. With more than 30 years of healthcare experience, Taylor will lead essential aspects of legal, compliance and privacy efforts, and will report to Biocept President and CEO Michael Nall. Taylor brings extensive healthcare and leadership experience, including over 20 years as a healthcare attorney honing his skills at the global law firm DLA Piper. He has provided legal, regulatory and compliance counsel to leading biopharmaceutical companies as well as numerous biotech start-ups. Most recently, Taylor served as Chief Compliance Officer for Precision Diagnostics, and its CLIA-certified and CAP-accredited clinical laboratory. Tillkännagivande • Dec 10
Biocept’s CNSide Cerebrospinal Fluid Assay Identifies Actionable HER2 Mutations in Patients with Breast Cancer that has Metastasized to the Brain Biocept, Inc. presented a study demonstrating the ability of its CNSide™ assay to identify HER2 and other actionable tumor alterations in the cerebrospinal fluid of patients with breast cancer and leptomeningeal disease (LMD). The poster was chosen for a Spotlight Presentation at the San Antonio Breast Cancer Symposium on Dec. 8, 2021. LMD is a devastating complication in which cancer spreads to the membrane surrounding the brain and spinal cord. The current standard of care for diagnosing LMD is through clinical evaluation, imaging and cytology, which have limited sensitivity and are unable to identify important tumor biomarkers such as HER2. HER2-targeted treatment for patients with breast cancer and LMD may provide substantial survival advantages over the expected median survival of less than three months. In this analysis, cerebrospinal fluid (CSF) of 63 patients with stage IV breast cancer and LMD was collected, and CSF tumor cells were captured and characterized using CNSide. HER2 amplification was detected in 56% of all patients. HER2 status differed between the primary tumor and LMD in 38% of cases, with more than 80% of those patients exhibiting a switch from a HER2-negative primary tumor to HER2-positive LMD. Tillkännagivande • Nov 24
Biocept Launches Combined COVID-19 and Influenza Test to Provide Answers During Peak Flu Season Biocept, Inc. now offers a single test that can detect and distinguish between SARS-CoV-2 and influenza, helping patients and caregivers determine appropriate treatment decisions. This new assay expands the company’s COVID-19 testing program, which began in June 2020 and has now received more than 670,000 samples for processing. Biocept’s combined COVID-19 and influenza testing uses a sensitive and specific RT-PCR platform to detect and distinguish between SARS-CoV-2 and influenza. Samples are collected through nasal swab and processed through Biocept’s CLIA-certified, CAP-accredited laboratory with results typically within approximately 48 hours from receipt of sample, providing timely and accurate results. Reported Earnings • Nov 16
Third quarter 2021 earnings released: EPS US$0.056 (vs US$0.43 loss in 3Q 2020) The company reported a strong third quarter result with improved earnings, revenues and profit margins. Third quarter 2021 results: Revenue: US$34.9m (up 431% from 3Q 2020). Net income: US$854.1k (up US$5.73m from 3Q 2020). Profit margin: 2.4% (up from net loss in 3Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 128% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. Tillkännagivande • Sep 24
Biocept, Inc. Implements Covid-19 Testing Program at Select California Community Colleges Biocept, Inc. has implemented its COVID-19 testing services at more than 30 community college campuses across California, streamlining the testing and tracking process for administrators, and allowing students and staff to easily schedule and complete COVID-19 testing. Since launching SARS-CoV-2 testing services for customers in June 2020, the company has received more than 570,000 samples for processing. Many California community colleges have established COVID-19 vaccine and testing policies for students and staff. To support these efforts, Biocept is providing PCR-based COVID-19 testing services that include conveniently located onsite sample collection at college campuses. Samples are collected by health care providers and processed at the company’s CLIA-certified, CAP-accredited laboratory, with results typically available within 48 hours of receipt. Biocept also offers a digital platform, created specifically for its customers, that provides an integrated system for tracking and managing COVID-19 testing programs. Los Angeles, San Diego and Riverside community colleges are among the first of a growing number of campuses that have implemented the digital platform, allowing students and administrators to record vaccinations, schedule weekly COVID-19 tests, track results and contact trace when necessary. Tillkännagivande • Sep 23
Biocept to Present Data at RAS-Targeted Drug Development Summit Showing Ability of Its Switch-BlockerTM Technology to Detect Rare Cancer Mutations Biocept, Inc. will present data on its Target Selector™ assay formats for the ultra-sensitive detection of KRAS mutations using Switch-Blocker™ technology, which provides advantages for the assessment of therapeutic tumor response and is cost effective for serial monitoring. The Summit brings together academic and biopharmaceutical leaders to share insights and data to advance the successful development of targeted monotherapies and combination strategies for RAS-driven cancers. RAS proteins are frequently mutated in cancers. In particular, KRAS mutations are present in approximately 25% of tumors, making them one of the most common gene mutations linked to cancer. They are drivers of some of the deadliest cancers, including lung, colorectal and pancreatic. As a result, there is significant interest among the biopharmaceutical and medical communities to develop and study new, highly targeted therapies to treat such cancers. To support these efforts, Biocept offers flexible molecular testing solutions based on advanced technology, including its proprietary Switch-Blocker technology. The company’s Target Selector assays and kits, combined with its Switch-Blocker technology, enables the development of superior assays to detect and characterize genetic alterations in patients with cancer. Switch-Blockers enrich for oncogenic mutations while suppressing wild-type (normal) DNA, resulting in ultra-high sensitivity and specificity. Biocept’s assays can be used to detect circulating tumor DNA (ctDNA) in tissue, blood and cerebrospinal fluid. For liquid biopsy applications, Switch-Blocker technology offers a 50- to 100-fold increase in mutant allele frequency of detection compared to conventional next-generation sequencing (NGS) and has been validated to 0.02% in blood. The technology offers similar analytical advantages in tissue, with the additional benefit of potentially reducing the Quantity Not Sufficient (QNS) rate because of the assay’s low sample input requirement compared to NGS-based assays. Biocept offers an expanded KRAS assay to detect a variety of KRAS mutations, as well as assays for a wide range of other mutations that are clinically actionable based on NCCN guidelines. It also can develop custom assays with high sensitivity and specificity based on the unique clinical trial needs of biopharmaceutical companies. These cost-effective assays are significantly less expensive than NGS-based tests, an important consideration for companies conducting clinical drug trials. Tillkännagivande • Aug 20
Biocept’s CNSide Assay Identifies Tumor Cells and Actionable Treatment Biomarkers from Cerebrospinal Fluid in Patients with Metastatic Non-Small Cell Lung Cancer Biocept announced that new data show the company’s cerebrospinal fluid assay, CNSide™, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy. The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021. More than 198,000 patients are diagnosed with non-small cell lung cancer (NSCLC) each year. An estimated 3-9% of those patients will develop leptomeningeal carcinomatosis (LMC), a complication in which the cancer spreads to the membranes surrounding the brain and spinal cord. LMC is typically diagnosed through clinical evaluation, imaging and cytology, which have limited sensitivity. When left untreated, the average patient life expectancy is just four to six weeks. The retrospective study, conducted at the University of Utah Huntsman Cancer Institute, used Biocept’s CNSide assay to detect and analyze tumor cells in the cerebrospinal fluid of 15 unique patients. Of the samples analyzed, CNSide detected tumor cells in 100% of samples with LMC, while cytology detected tumor cells in just 40% of the samples. CNSide also identified actionable biomarkers in tumor cells, which allowed oncologists to make targeted treatment decisions that reduced debilitating symptoms and extended patient lives by more than three years in some cases. The study results suggest that CNSide is more sensitive than cytology, and survival of patients with LMC can be prolonged if an actionable target is identified and treated. Reported Earnings • Aug 18
Second quarter 2021 earnings released: US$0.14 loss per share (vs US$0.51 loss in 2Q 2020) The company reported a solid second quarter result with reduced losses, improved revenues and improved control over expenses. Second quarter 2021 results: Revenue: US$12.0m (up US$11.1m from 2Q 2020). Net loss: US$1.83m (loss narrowed 72% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 122% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Tillkännagivande • Jul 24
Medicare Issues Local Coverage Determination for Biocept’s Target Selector™ Breast Cancer Assay to Detect the HER2 Biomarker from Circulating Tumor Cells Biocept, Inc. has received a positive final Local Coverage Determination (LCD) that expands Medicare coverage for use of its Target Selector assay to identify the HER2 biomarker from circulating tumor cells (CTCs). This coverage determination from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDx) was effective July 4, 2021. About 20% of breast cancers are HER2-positive, with metastatic cancers more likely to be HER2-positive and approximately 20% of HER2-positive patients experiencing recurrence each year. Given the efficacy of various anti-HER2 therapies, testing for HER2 is one of the most important sources of information used by oncologists in making treatment decisions for patients with breast cancer. As a result, guidelines for breast cancer recommend that all patients with new primary or newly metastatic breast cancer be tested for HER2. Traditionally, testing has been performed using tissue. However, adequate tissue from the original biopsy may not be available, and additional invasive biopsy procedures are often impractical and associated with complications. The MolDx program was developed by CMS to identify and establish coverage and reimbursement for molecular diagnostic tests. To receive a favorable MolDx coverage determination, assays must demonstrate clinical utility, fulfill the CMS reasonable and necessary criteria, and meet analytical and clinical validity standards. Biocept’s combined cell-based and cell-free liquid biopsy tests assess actionable cancer biomarkers from a patient’s blood and, uniquely, from cerebrospinal fluid (CSF) as well. Following the full commercial launch of its CSF assay, CNSide, Biocept submitted an initial application for Breakthrough Device Designation to the U.S. Food and Drug Administration (FDA). While the initial submission was recently denied, the company continues to pursue Breakthrough Device Designation for CNSide and is gathering data based on the feedback provided by the FDA to further support its submission. The test is currently marketed as a Lab Developed Test (LDT) in Biocept’s CLIA certified and CAP accredited lab. CNSide is designed to improve the clinical management of patients with suspected metastatic cancer involving the central nervous system. The company also continues to provide COVID-19 testing services to help manage the impact of COVID-19 in long-term care facilities, schools and other public facilities it serves. Biocept has received more than 450,000 samples for SARS-CoV-2 testing since launching this service in June 2020. The samples are processed using Biocept’s RT-PCR-based technology at its CLIA-certified, CAP-accredited, high-complexity molecular laboratory in San Diego. Reported Earnings • May 14
First quarter 2021 earnings released: EPS US$0.19 (vs US$1.06 loss in 1Q 2020) The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$17.8m (up US$16.3m from 1Q 2020). Net income: US$2.60m (up US$10.9m from 1Q 2020). Profit margin: 15% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Reported Earnings • Mar 30
Full year 2020 earnings released: US$1.50 loss per share (vs US$12.23 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: US$27.5m (up 397% from FY 2019). Net loss: US$17.8m (loss narrowed 30% from FY 2019). Tillkännagivande • Mar 04
Aegea Biotechnologies Announces Supply Agreement with Biocept for New COVID-19 Test with the Ability to Distinguish Virus Strains and Quantify Viral Load Aegea Biotechnologies, Inc. and Biocept, Inc. announced a supply agreement for a new PCR-based COVID-19 assay kit designed by Aegea and co-developed by the companies. Under the agreement, Aegea will supply the COVID-19 assay kit to Biocept for validation in its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent commercialization of a laboratory developed test (LDT). The new COVID-19 assay is a next-generation PCR-based test using proprietary Switch-Blocker technology for viral RNA detection as well as discrimination of L- and S-strain types. As a result of this core technology, which enables robust single nucleotide discrimination, the assay has several technical advantages compared with other COVID-19 PCR assays. The assay may have the ability to evaluate sample adequacy in patients with negative results and be adapted to identify new variants of the SARS-CoV-2 virus as they emerge. It is expected to allow quantitative evaluation of viral load to better assist healthcare providers who are screening asymptomatic patients, managing patients with symptomatic infections, or evaluating patients who are recovering from COVID-19. Switch-Blocker technology used in the COVID-19 test, which also is the basis for Biocept’s ultra-sensitive oncology assays, is patent protected in the United States and 10 other major jurisdictions. The intellectual property underlying the Switch-Blocker technology is jointly owned by Biocept and Aegea. Under Biocept and Aegea’s cross-licensing agreement relating to the Switch-Blocker intellectual property, Aegea has exclusive rights in infectious diseases and other fields, and Biocept has certain rights within the field of clinical oncology. Tillkännagivande • Feb 24
Biocept and Protean BioDiagnostics Establish Research Collaboration to Demonstrate Advantages of Biocept’s Target Selector™ Assay Kit for Non-Small Cell Lung Cancer Patients Biocept, Inc. will collaborate with Protean BioDiagnostics Inc. to research the ability of Biocept’s Target Selector™ molecular assay to determine EGFR status in non-small cell lung cancer (NSCLC) patients. The research will be conducted in an independent pathology laboratory setting. Protean BioDiagnostics also expects to validate the analytical performance of a laboratory developed test (LDT) based on Biocept’s EGFR assay test kit in accordance with the requirements of the College of American Pathologists (CAP) validation process. Biocept’s novel molecular assay kit, available for research-use-only and with CE-IVD mark, enables molecular laboratories around the world to utilize its Target Selector platform to analyze both formalin-fixed paraffin-embedded (FFPE) tissue samples and circulating tumor DNA (ctDNA) from biological fluids. Target Selector leverages patented Switch-Blocker technology to enrich specimens for mutations of interest and block DNA amplification from normal cells, requiring less tumor sample and resulting in higher assay sensitivity than most commercial assays. Biocept’s molecular assays have been validated for the detection of frequent oncogenic mutations EGFR, KRAS and BRAF, which are among the most frequently evaluated biomarkers for lung cancer and melanoma. Is New 90 Day High Low • Feb 06
New 90-day high: €6.05 The company is up 59% from its price of €3.80 on 06 November 2020. The German market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 9.0% over the same period. Is New 90 Day High Low • Jan 20
New 90-day high: €5.10 The company is up 36% from its price of €3.76 on 22 October 2020. The German market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 9.0% over the same period. Tillkännagivande • Dec 31
Biocept, Inc. Enters into Laboratory Services Agreements with Independent Physician Associations Biocept, Inc. announced that it has entered into laboratory services agreements with independent physician associations providing physicians and patients in-network access to Biocept's full array of Target Selector™ liquid biopsy oncology assays and services. Both IPAs are headquartered in San Diego and combined serve more than 70,000 covered lives in the Southern California region. Tillkännagivande • Dec 15
Biocept, Inc. Announces to Receives More Than 150,000 Samples for Covid-19 RT-PCR Testing Biocept, Inc. announced that it has received more than 150,000 samples for COVID-19 RT-PCR testing to date and has continued to report the vast majority of results to customers within 48 hours of receiving a sample. The Company also announces the successful relocation to its new corporate headquarters and molecular laboratory facility in San Diego. Tillkännagivande • Dec 13
Biocept, Inc.'s Target Selector™ Liquid Biopsy Demonstrate High Accuracy When Used for Monitoring the Progression of Metastatic Breast Cancer in Study Conducted at Johns Hopkins Sidney Kimmel Cancer Center Biocept, Inc. announced results from a prospective study showing Target Selector™ was highly accurate in monitoring HER2 alterations in patients with metastatic breast cancer. The results were featured in a poster presentation by Vered Stearns, M.D., professor of oncology, breast cancer research chair in oncology, and director of the Women's Malignancies Disease Group at Johns Hopkins University School of Medicine/Johns Hopkins Sidney Kimmel Cancer Center, at the virtual 2020 San Antonio Breast Cancer Symposium® (SABC®). Is New 90 Day High Low • Dec 12
New 90-day high: €4.80 The company is up 30% from its price of €3.69 on 07 September 2020. The German market is up 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Reported Earnings • Nov 21
Third quarter 2020 earnings released: US$0.43 loss per share The company reported a solid third quarter result with reduced losses and improved revenues and control over expenses. Third quarter 2020 results: Revenue: US$6.59m (up 331% from 3Q 2019). Net loss: US$4.88m (loss narrowed 14% from 3Q 2019). Analyst Estimate Surprise Post Earnings • Nov 21
Revenue beats expectations Revenue exceeded analyst estimates by 163%. Over the next year, revenue is forecast to grow 154%, compared to a 196% growth forecast for the Biotechs industry in Germany. Reported Earnings • Nov 17
Third quarter 2020 earnings released: US$0.43 loss per share The company reported a solid third quarter result with reduced losses and improved revenues and control over expenses. Third quarter 2020 results: Revenue: US$6.59m (up 331% from 3Q 2019). Net loss: US$4.88m (loss narrowed 14% from 3Q 2019). Analyst Estimate Surprise Post Earnings • Nov 17
Revenue beats expectations Revenue exceeded analyst estimates by 163%. Over the next year, revenue is forecast to grow 154%, compared to a 325% growth forecast for the Biotechs industry in Germany. Tillkännagivande • Nov 10
Biocept, Inc. Receives Hong Kong Patent Covering the Enhanced Detection of Rare Cells, Including Cancer Cells Biocept, Inc. announced that it has been awarded Hong Kong Patent No. 1188285 entitled, METHODS AND REAGENTS FOR SIGNAL AMPLIFICATION. This patent covers methods for enhancing the detection of cells using fluorescent complexes, including circulating tumor cells. The method covered by this patent expands Biocept's patent protection for sensitive detection of cancer cells. This technology combines seamlessly with Biocept's core technologies using antibodies for CTC enrichment, as well as Biocept's microchannel intellectual property for the capture, enrichment, and imaging of CTCs from patients with cancer collected in Biocept's patented blood transport tube. This could also be important in future applications such as with Single Cell Analysis. Tillkännagivande • Nov 06
Biocept, Inc. to Report Q3, 2020 Results on Nov 12, 2020 Biocept, Inc. announced that they will report Q3, 2020 results at 5:00 PM, W. Europe Standard Time on Nov 12, 2020 Tillkännagivande • Oct 07
Biocept, Inc. Provides Update on COVID-19 Testing with More than 50,000 Specimens Received Biocept, Inc. announced it has received more than 50,000 COVID-19 specimens to date for processing through its RT-PCR technology at its CLIA-certified, CAP-accredited high-complexity molecular laboratory. Biocept is also reporting progress with its internally developed COVID-19 specimen collection kits. The Company has received verification from a contract research organization (CRO) of the viricidal effects of the specimen collection tube used for shipping patient samples. This was an important gating factor prior to the adoption of the internally developed kits. The Biocept-developed COVID-19 specimen collection kit will now be validated as part of the Company's COVID-19 workflow in the Company's lab prior to being sent to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EAU) review. Biocept remains on track for launching the Biocept-developed specimen collection kits later this year for use in its lab and for potential sales to other labs. Is New 90 Day High Low • Sep 25
New 90-day low: €3.62 The company is down 42% from its price of €6.25 on 26 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Tillkännagivande • Sep 22
Biocept, Inc. Announces That Highmark Has Made A Positive Coverage Determination on Target Selector Liquid Biopsy Biocept, Inc. announced that Highmark, America's fourth largest Blue Cross Blue Shield affiliate, has made a positive coverage determination that Biocept's Target Selector liquid biopsy assay has been accepted for medical coverage for use in the diagnosis and treatment of patients with non-small cell lung cancer (NSCLC). The coverage determination follows two years of evaluation performed by the Allegheny Health Network Cancer Institute of Biocept's liquid biopsy assay to more rapidly assess the molecular status of patients with NSCLC, enabling oncologists to select the most appropriate therapy while also reducing the overall cost of care. Highmark's coverage determination includes testing with Biocept's assay in health insurances across the insurer's footprint, which includes Pennsylvania, Delaware and West Virginia, where it serves 5.6 million members. The evaluation was managed by Highmark Health's VITAL Innovation Platform, which facilitates real-world testing of early-stage health innovations, producing evidence related to patient experience, care, and cost outcomes to support potential adoption within Highmark Health, as well as acceleration into the broader healthcare community. Highmark will be the first insurer in its footprint to provide coverage of the test. In addition, Allegheny Health Network is the first health system to offer the testing in Highmark's footprint, with others to follow. The Biocept Target Selector platform was used to molecularly profile the liquid biopsies of newly diagnosed, treatment-naïve advanced NSCLC patients, as well as NSCLC patients who were progressing after initial therapy. These patients also received tissue biopsy as part of the evaluation. Lung cancer is the leading cause of cancer death in the United States. The American Cancer Society estimates that approximately 135,720 Americans will die from lung cancer in 2020. The five-year survival rate for advanced NSCLC is less than 10%. However, 17–27% of NSCLC patients harbor molecular alterations that can be treated with specific FDA-approved targeted therapies. Despite the advances of targeted therapies, a large percentage of patients may not undergo molecular profiling due to a number of practical constraints. Chief among these is the availability of tissue for molecular testing. Lung cancers are often difficult to biopsy because of their location within what is often diseased lung tissue of elderly patients. Needle biopsy is the most common technique but often does not yield enough tissue for molecular testing. Performing a second biopsy is a way of remedying this situation, but these procedures can add to risk and cost, making liquid biopsy (peripheral blood) a more feasible specimen type. Is New 90 Day High Low • Sep 19
New 90-day low: €3.69 The company is down 50% from its price of €7.40 on 19 June 2020. The German market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Tillkännagivande • Sep 05
Biocept, Inc. Announces One-For-Ten Reverse Stock Split to Regain Compliance Biocept, Inc. announced that, as a result of the Company's one-for-ten reverse stock split which will become effective at 5:00 p.m. Eastern Time on September 4, 2020, the Company's common stock will begin trading on a split-adjusted basis on The Nasdaq Capital Market ("Nasdaq") effective with the open of the market on Tuesday, September 8, 2020. Biocept's common shares will continue to trade under the ticker symbol "BIOC." Authorization for the reverse stock split was approved by the Company's stockholders at Biocept's 2020 Annual Meeting of Stockholders. The objective of the reverse stock split is to increase the market price for the Company's common stock to, among things, enable the Company to regain compliance with the $1.00 minimum bid price requirement under applicable Nasdaq Listing Rules. Tillkännagivande • Aug 06
Biocept, Inc. to Report Q2, 2020 Results on Aug 12, 2020 Biocept, Inc. announced that they will report Q2, 2020 results on Aug 12, 2020