Anuncio • May 28
ENDRA Life Sciences Inc. announced that it expects to receive $3.800003 million in funding ENDRA Life Sciences Inc. has entered into a securities purchase agreement with an accredited investor pursuant to which the Company agreed to sell and issue to an aggregate of 578,387 shares at an issue price of $6.57 for gross proceeds of $ 38,00,002.59 and and warrants (the “Common Warrants”) to purchase an aggregate of up to 1,156,774 shares of Common Stock at a per share exercise price of $6.57 On May 27, 2026. The Offering is expected to close on May 28, 2026. The transaction is pursuant to Regulation D. Anuncio • May 27
ENDRA Life Sciences Inc. has withdrawn its Follow-on Equity Offering. ENDRA Life Sciences Inc. has withdrawn its Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,700,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 15,700,000 Anuncio • May 15
Endra Life Sciences Inc Announces Multi-Site Validation of Taeus Liver Device Demonstrating Mri-Like Accuracy and Reproducibility Endra Life Sciences Inc. announced multi-site clinical validation results for TAEUS Liver that demonstrate strong concordance with MRI-PDFF, high reproducibility and consistent performance across clinical sites. The analysis combined data from 64 patients in the U.S. and Canada, including an external validation site in London, Ontario, across independent operators and patient populations. TAEUS Liver’s thermoacoustic fat fraction measurement closely tracked MRI-PDFF results for patients along the full spectrum of metabolic dysfunction-associated steatotic liver disease (MASLD) and those with elevated body mass index (BMI). Key results in the analysis included: Correlation to MRI-PDFF: r=0.90 (combined cohort); Diagnostic accuracy: AUROC 0.95–0.99 at key thresholds; Mean error: ~3%, consistent across sites; Reproducibility: ICC=0.89 across operators; ~90% of measurements within ~5% of MRI values; No dependence on BMI or body habitus. TAEUS Liver is designed to provide MRI-aligned performance in a portable, point-of-care format with an anticipated per-scan cost of under $200, which is less than 8% of a typical MRI-PDFF exam. By enabling frequent, affordable assessments, TAEUS Liver could support routine monitoring of treatment-driven changes in liver fat that are difficult to track with MRI alone. The TAEUS system's performance contrasts sharply with ultrasound techniques, which experience high inter-observer variability and subjective interpretations. These study results support TAEUS Liver’s objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS Liver could be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials. As new metabolic therapies enter the market, the ability to detect small, incremental changes in liver fat without the cost burden of repeated MRI scans becomes increasingly important. ENDRA’s innovative approach with TAEUS combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems. Anuncio • Apr 22
ENDRA Life Sciences Inc. Announces Non-Compliance With Nasdaq Minimum Stockholders' Equity Requirement As previously reported, on May 27, 2025, ENDRA Life Sciences Inc. (the Company) received a notification letter from The Nasdaq Stock Market LLC (Nasdaq) Listing Qualifications Staff (the Staff) notifying the Company that its stockholders' equity had fallen below the $2,500,000 required minimum for continued listing set in Nasdaq Listing Rule 5550(b)(1) (the Minimum Stockholders' Equity Requirement). The notification letter stated that the Company had until July 11, 2025 to provide Nasdaq with a specific plan to achieve and sustain compliance. The Company submitted its plan to regain compliance on July 11, 2025 and subsequently provided the Staff with additional materials. On October 31, 2025, the Company received written notice that, based on review of the compliance plan and additional materials, the Staff had granted the Company an extension to November 24, 2025 to regain compliance with the Minimum Stockholders' Equity Requirement. Subsequently, on November 18, 2025, based on the Staff's review of the Company's Form 8-K, dated November 14, 2025, the Staff determined that the Company regained compliance with Minimum Stockholders' Equity Requirement, subject to Nasdaq's continued monitoring of the Company's ongoing compliance with the Minimum Stockholders' Equity Requirement. Under such monitoring, if at the time of the Company's periodic report following having regained compliance, the Company did not evidence continued compliance, it may be subject to delisting. On April 20, 2026, the Staff issued a letter to the Company indicating that, because the Company's stockholders' equity as reported in its Annual Report on Form 10-K for the year ended December 31, 2025 was $2,260,120, the Company is no longer in compliance with Minimum Stockholders' Equity Requirement. The Staff's letter indicated that the Company's non-compliance would result in the delisting of the Company's securities from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the Panel). The Company intends to timely request a hearing before the Panel, which request will stay any further action by Nasdaq pending the issuance of a decision by the Panel and the expiration of any extension the Panel may grant to the Company following the hearing. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company is currently evaluating its available options to resolve the deficiency and regain compliance with the Minimum Stockholders' Equity Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Stockholders' Equity Requirement, maintain compliance with the other Nasdaq listing requirements or be successful in appealing the delisting determination. New Risk • Apr 04
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$8.2m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.2m free cash flow). Shareholders have been substantially diluted in the past year (107% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$5.47m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$6.4m net loss next year). Share price has been volatile over the past 3 months (12% average weekly change). Anuncio • Feb 26
ENDRA's TAEUS Liver Device Demonstrates High-Level Consistency in Clinical Study, Delivering MRI-Level Results at the Point of Patient Care ENDRA Life Sciences Inc. announced favorable results from a clinical study evaluating the measurement consistency of its TAEUS Liver device. The study demonstrated the device's robust intra-user repeatability and inter-user reproduibility, essential factors for long-term monitoring of Metabolic Dysfunction-Associated Steatotic Liver disease (MASLD), which now affects approximately 30% of adults worldwide. The study involved 14 subjects with independent operators performing several measurements each to assess the platform's performance in real-world clinical conditions. This addresses a critical need for clinicians and pharmaceutical companies that require a diagnostic tool to monitor treatment frequently and affordably." The TAEUS system's performance also contrasts sharply with traditional ultrasound techniques, which suffer from high inter-observer variability and subjective interpretations. These study results support TAEUS's objective to deliver a standardized, accurate and repeatable liver fat test for the growing population affected by MASLD. TAEUS could be deployed in routine clinical practice to address large, underserved populations and could potentially be utilized by pharmaceutical companies for patient recruitment and follow-up in clinical trials. As new metabolic therapies enter the market, the ability to detect small, incremental changes in liver fat without the cost burden of repeated MRI scans becomes increasingly important. ENDRA's innovative approach with TAEUS seamlessly combines the precision traditionally associated with expensive imaging modalities with the practical deployment advantages of ultrasound-based systems. Anuncio • Dec 04
Endra's Taeus Liver Matches Mri-Pdff Performance At Key Clinical Thresholds, Positioning Device for Masld/Mash Trial Use ENDRA Life Sciences Inc. announced new results from its 2025 TAEUS Liver device feasibility study demonstrating that TAEUS' thermo-acoustic fat fraction (TAFF) measurement closely tracks the MRI-PDFF gold standard at critical liver fat fraction (LFF) thresholds of 12-17% and 20-22%. These thresholds separate mild, moderate and severe disease, are widely used to make clinical therapy decisions in routine practice and are important for enrolling patients in clinical trials. In the recently completed feasibility study of 40 subjects with BMI ranging from 21 to 47, ENDRA evaluated the performance of its TAFF biomarker test against MRI-PDFF at decision thresholds that segment patients from mild to moderate-to-severe steatosis. TAEUS is designed to disrupt this model and make liver fat quantification far more accessible by offering a point-of-care imaging solution at an anticipated cost of less than $200 (or less than 8% the cost of an MRI-PDFFexam) and the ability to perform frequent, longitudinal monitoring (e.g., every 8 weeks) to capture rapid drug-induced changes in LFF, which is impractical with MRI. The feasibility study results de-risk several potential value-creating pathways for ENDRA: Pharma Partnerships: Enable pilot integrations in ongoing trials, potentially using a hybrid model (e.g., TAEUS for frequent checks, MRI-PDFF for confirmation) to drastically reduce imaging costs. Scalable Model: Leverage existing global ultrasound infrastructure for a capital-efficient, usage-based revenue model tied to the growing MASLD/MASH population and clinical trials volume. Regulatory pathway: ENDRA plans to engage the FDA in 2026 on the pivotal study design, endpoints and statistical plan, seeking alignment prior to study initiation in support of a subsequent De Novo submission. Anuncio • Nov 29
ENDRA Life Sciences Inc. Announces Resignation of Michael Thornton as Chief Technology Officer, Effective November 28, 2025 On November 28, 2025, ENDRA Life Sciences Inc. (the “Company”) entered into a Consulting Agreement with Michael Thornton (the “Consulting Agreement”), in connection with which Mr. Thornton resigned as the Company’s Chief Technology Officer effective on such date. New Risk • Nov 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (117% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.21m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$7.5m net loss next year). Anuncio • Nov 22
ENDRA Life Sciences Inc. Announces Preliminary Results from A Single-Site Clinical Feasibility Study Evaluating Its Improved TAEUS Liver Device for Quantifying Liver Fat Fraction ENDRA Life Sciences Inc. announced encouraging preliminary results from a single-site clinical feasibility study evaluating its improved TAEUS Liver device for quantifying liver fat fraction, which is a key biomarker of steatotic liver disease ("SLD"). The preliminary study results indicate the ability of the TAEUS Liver test to accurately quantify liver fat across the full SLD spectrum, with predictive values closely aligned with the imaging gold standard of MRI-PDFF, a non-invasive imaging technique that uses MRI to quantify the amount of fat in a tissue. These findings strongly support TAEUS's potential as an accurate, non-invasive and cost-effective point-of-care solution that could address the limitations of existing solutions. The feasibility study was designed to validate the device's improved performance and de-risk the design and statistical plan leading to the U.S. Food and Drug Administration ("FDA") pivotal study. Results will be discussed with the FDA in pre-submission meetings prior to initiating the pivotal study and also will be submitted for publication in a peer-reviewed medical journal. Study Overview: TAEUS biomarker: Thermoacoustic Fat Fraction (TAFF); Comparator: Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF), the recognized imaging gold standard for liver fat quantification; Participants: 40 subjects with BMI ranging from 21 to 47; full SLD spectrum of healthy to severe; Analyses: Deming regression, Bland-Altman error plot and Pearson correlation. Clinical and Market Context: Large unmet need: More than 2 billion people worldwide including over 100 million in the U.S. are affected by SLD. Evolving guidance: Professional societies including AASLD, EASL, the American Diabetes Association and the American Association of Clinical Endocrinology emphasize early screening and ongoing monitoring for SLD. Robust therapeutics pipeline: 50+ GLP-1 and other agents in Phase 2 and Phase 3 trials for obesity, type 2 diabetes and MASLD/MASH require accurate, repeatable liver fat quantification for patient selection and monitoring. Cost/access gap: MRI-PDFF typically costs over $2,500 per exam and is generally not reimbursed, limiting frequent assessments across 6 to 18 month studies even as some GLP-1s show liver fat changes in less than eight weeks. Point-of-care opportunity: As a portable, low-cost modality, TAEUS aims to deliver MRI-PDFF-like performance at the point of patient care to enable practical, frequent monitoring. Key Findings: Strong agreement with MRI-PDFF across the full SLD spectrum: Deming regression showed TAFF with a slope of 1 and an intercept of 0, both within the 95% confidence intervals relative to MRI-PDFF. Pearson correlation efficient r=0.89. Deming regression is commonly referenced by the FDA when evaluating new diagnostic technologies. Together, the Deming and Pearson results demonstrate strong statistical agreement with the recognized imaging gold standard. Consistent accuracy across BMI and disease severity: The Bland-Altman analysis showed >90% of subjects fall within a 5% error margin versus MRI-PDFF, with an average error of ~3%. The observed error is small and remained consistent across both the BMI range and fatty liver disease stages, contrasting with many ultraound-based fat estimation methods where error typically typically associated with many ultra-invasive and cost- effective point-of-care solutions. Anuncio • Oct 30
ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $1.75 million. ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $1.75 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Anuncio • Oct 24
ENDRA Life Sciences Inc. announced that it has received $4.9 million in funding On October 23, 2025, ENDRA Life Sciences Inc. closed the transaction. The company raised funding pursuant to Regulation D from 6 investors. Anuncio • Oct 21
ENDRA Life Sciences Inc., Annual General Meeting, Dec 09, 2025 ENDRA Life Sciences Inc., Annual General Meeting, Dec 09, 2025. New Risk • Aug 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (41% average weekly change). Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 16x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.28m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$8.0m net loss next year). Anuncio • Jul 10
ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering. ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,700,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 15,700,000 Anuncio • Jun 18
Endra Life Sciences Inc.'S Ongoing Multisite Pilot Study Reveals Important Enhancements to Boost Taeus Liver Accuracy and Repeatability Against Mri Gold Standard ENDRA Life Sciences Inc. announced that its ongoing multisite pilot study has helped to identify several product enhancements to further improve the performance of its TAEUS®? Liver system against the gold standard, MRI. These findings are expected to drive substantial improvements to the device's probe design and proprietary algorithms, measurably improving diagnostic accuracy and repeatability. These enhancements are currently being implemented and are expected to strengthen the outcomes of the Company's planned U.S. Food and Drug Administration ("FDA") De Novo pivotal study. Consistent with its revamped go-to-market strategy, ENDRA is conducting a multisite clinical initiative designed to bolster the diagnostic performance of TAEUS Liver prior to initiation of the FDA pivotal study. In collaboration with several leading imaging centers, the Company has collected liver fat measurement data from more than 100 subjects that compare TAEUS scans against MRI-PDFF. Building on this momentum, ENDRA plans to add several clinical sites to the ongoing clinical pilot study in the U.S. and Canada to confirm the anticipated gains of the TAEUS probe and algorithm enhancements. Armed with this additional data, ENDRA expects to be well-positioned to align with the FDA on the TAEUS Liver device's pivotal study endpoints and final protocol, which will serve as the basis for a De Novo submission. In a decisive shift, late last year the Company overhauled its clinical and regulatory strategy. Instead of relying on retrospective data from a limited number of subjects, ENDRA implemented a 100+ patient pilot study to validate and finetune TAEUS algorithms and design. Subsequent to the completion of the pilot study and pending alignment with the FDA, ENDRA plans to conduct a prospective, hypothesis-driven, statistically powered, multisite pivotal clinical study that is expected to enroll approximately 250 patients. This plan is intended to deliver robust evidence for a De Novo submission to the FDA, ensuring scientific rigor to support a successful regulatory outcome. Anuncio • May 30
ENDRA Life Sciences Receives Non-Compliance Notice from Nasdaq Minimum Stockholders Equity Requirement On May 27, 2025, ENDRA Life Sciences Inc. (the Company") received a letter from The Nasdaq Stock Market LLC (Nasdaq") indicating that, because the Company's stockholders' equity as reported in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 was $1,752,885, the Company is no longer in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders' equity for continued listing. Nasdaq's letter has no immediate impact on the listing of the Company's common stock, which will continue to be listed and traded on The Nasdaq Capital Market, subject to the Company's compliance with the other continued listing requirements. Nasdaq's letter provides the Company 45 calendar days, or until July 11, 2025, to submit a plan to regain compliance. If the plan is accepted, the Company can be granted up to 180 calendar days from May 27, 2025 (or until November 23, 2025), to evidence compliance. There can be no assurance that the Company will be able to regain or maintain compliance with all applicable continued listing requirements or that its plan will be accepted by the Nasdaq staff. In the event the plan is not accepted by the Nasdaq staff, or in the event the plan is accepted but the Company fails to regain compliance within the plan period, the Company would have the right to a hearing before an independent panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal any delisting determination by Nasdaq to a panel, that such appeal would be successful. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company is currently evaluating its available options to resolve the deficiency and regain compliance with the Nasdaq minimum stockholders' equity requirement. The Company intends to submit the compliance plan by the Nasdaq deadline. However, there can be no assurance that the Company's compliance plan will be accepted by Nasdaq, that it be able to regain compliance with Nasdaq Listing Rule 5550(b)(1), maintain compliance with the other Nasdaq listing requirements or be successful in appealing any delisting determination. Anuncio • Apr 01
ENDRA Life Sciences Announces Enhanced Strategy to Enable the Early Detection and Management of Metabolic Diseases Facilitated by Emerging GLP-1 Therapies ENDRA Life Sciences Inc. announced a new strategic direction to develop and deploy its TAEUS system as a biomarker solution for the early detection and management of metabolic diseases in patients being treated with glucagon-like peptide-1 (GLP-1) drugs and other metabolic dysfunction-associated steatohepatitis (MASH) therapies. ENDRA’s management has thoroughly evaluated the Company’s technical capabilities and go-to-market strategy for TAEUS Liver and determined that this new target market opportunity is far larger and more viable than its prior focus on hepatology and radiology markets, noting that metabolic diseases are an upstream phenomenon that lead to multiple risk factors including those specific to liver diseases. With this pivot toward metabolic health, ENDRA’s revised mission is to develop and market an accurate, simple-to-use, inexpensive, point-of-care test – essentially a “blood pressure cuff” – for the assessment and management of steatotic liver disease (SLD). Board Change • Feb 15
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 4 highly experienced directors. Independent Director Lou Basenese was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Anuncio • Nov 22
ENDRA Life Sciences Regains Compliance with Nasdaq Minimum Bid Price Requirement ENDRA Life Sciences Inc. announced that it has regained compliance with the minimum bid price requirement set by The Nasdaq Stock Market LLC (‘Nasdaq’). On November 21, 2024, the Company received notification from the Nasdaq Listing Qualifications Department confirming its compliance with Listing Rule 5550(a)(2), thereby meeting Nasdaq’s maintenance requirements for listing. ‘Now that we have regained compliance with Nasdaq’s listing requirements, we can focus all our efforts on making progress on our new transformational business strategies, which we reviewed during our August 22nd conference call,’ said Alex Tokman, acting Chief Executive Officer of ENDRA. Anuncio • Nov 17
ENDRA Life Sciences Inc. announced delayed 10-Q filing On 11/15/2024, ENDRA Life Sciences Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Anuncio • Nov 13
Study Highlighting ENDRA Life Sciences’ TAEUS Technology in Patients with High BMI to be Presented at AASLD’s The Liver Meeting 2024 ENDRA Life Sciences Inc. announced the acceptance of a poster titled “Noninvasive assessment of steatotic liver disease in individuals with class 2 and class 3 obesity” for presentation at The Liver Meeting 2024, hosted by the American Association for the Study of Liver Disease (AASLD), taking place November 15-19 in San Diego. This presentation highlights the potential of TAEUS technology to obtain liver fat fraction measurements in patients with body mass index (BMI) exceeding 35, where accurate and reliable assessment of liver fat is challenging with existing point-of-care solutions. In extreme cases, TAEUS was able to obtain valid measurements of fat fraction in subjects with BMI exceeding 40, where the liver was more than 40mm below the skin surface. The subjects in this presentation were derived from a larger study comparing the performance of TAEUS to MRI measurements of fat fraction in the liver. Publication Number: 2089. Title: Noninvasive assessment of steatotic liver disease in individuals with class 2 and class 3 obesity. Presenter: Michael Thornton. Session: Diagnostics and Biomarkers - MASH. Date: November 16, 2024. Time:8:00am – 5:00pm Pacific Standard Time. The poster will be available on the Research and Media [2] section of ENDRA's website after the conference ends. Anuncio • Aug 29
Nasdaq Hearings Panel Grants ENDRA Life Sciences an Extension to Regain Compliance with Nasdaq Continued Listing Requirements ENDRA Life Sciences Inc. announced that on August 27, 2024, the Company was notified by The Nasdaq Stock Market LLC (‘Nasdaq’) that the Nasdaq Hearings Panel (the ‘Panel’) has granted the Company’s request for an extension through November 20, 2024, to evidence compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. To regain compliance with the bid price requirement, the Company must evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive trading sessions on or before November 20, 2024. The Company is considering all available options to timely evidence compliance with the terms of the Panel’s decision. This notification from Nasdaq has no immediate effect on the listing or trading of the Company's common stock, which will continue to trade on the Nasdaq Capital Market under the symbol ‘NDRA’. Anuncio • Aug 20
ENDRA Life Sciences Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market ENDRA Life Sciences Inc. announced that it will implement a 1-for-50 reverse stock split of the issued shares of its common stock, effective at 12:01 a.m. Eastern time on August 20, 2024. The Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on August 20, 2024, and will continue to trade on The Nasdaq Capital Market under the symbol 'NDRA.' The new CUSIP number for the common stock will be 29273B 401. The Reverse Stock Split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company's stockholders authorized the reverse stock split at the Company's annual meeting of stockholders held on August 6, 2024, with the final ratio subsequently determined by the Company's Board of Directors. New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.0m free cash flow). Share price has been highly volatile over the past 3 months (32% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 8x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.65m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). Anuncio • Aug 07
ENDRA Life Sciences Inc. to Report Q2, 2024 Results on Aug 14, 2024 ENDRA Life Sciences Inc. announced that they will report Q2, 2024 results After-Market on Aug 14, 2024 Anuncio • Jul 18
ENDRA Life Sciences Receives Notice from the Listing Qualifications Staff of the Nasdaq Stock Market As previously disclosed, the Listing Qualifications Staff of The Nasdaq Stock Market LLC notified ENDRA Life Sciences Inc. on May 3, 2024 that the bid price of the Company’s common stock had closed at less than $1.00 per share for 30 consecutive business days and, as a result, did not comply with Nasdaq Listing Rule 5550(a)(2). Therefore, in accordance with Listing Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until October 30, 2024, to regain compliance with the Minimum Bid Price Requirement. On July 15, 2024, the Company received notice from the Staff indicating that the bid price for the Company’s common stock had closed below $0.10 per share for the 10-consecutive trading day period ended July 12, 2024 and, accordingly, the Company is subject to the provisions contemplated under Nasdaq Listing Rule 5810(c)(3)(A)(iii). As a result, the Staff determined to delist the Company’s common stock from The Nasdaq Capital Market. On July 16, 2024, the Company timely requested a hearing before a Nasdaq Hearings Panel to appeal the Delisting Determination. The hearing request automatically stays any suspension or delisting action pending the hearing and the expiration of any compliance period granted by the Panel following the hearing. Notwithstanding the Company’s request for a hearing, there can be no assurance that the Panel will grant the Company any compliance period or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. The Company is monitoring the closing bid price of its common stock and will consider options to regain compliance with the Minimum Bid Price Requirement, including holding the previously disclosed annual meeting of stockholders on August 6, 2024. At the Annual Meeting, the Company will seek stockholder approval for the implementation of a reverse stock split of the Company’s common stock at a ratio between 1-for-20 and 1-for-50, inclusive, with the ultimate ratio to be determined by the Company’s board of directors in its sole discretion. Anuncio • Jun 15
ENDRA Life Sciences Inc., Annual General Meeting, Aug 06, 2024 ENDRA Life Sciences Inc., Annual General Meeting, Aug 06, 2024. Major Estimate Revision • Jun 10
Consensus revenue estimates decrease by 50%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$200.0k to US$100.0k. EPS estimate increased from -US$1.06 to -US$0.23 per share. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target down from US$10.00 to US$8.00. Share price fell 48% to US$0.11 over the past week. New Risk • Jun 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 129% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (32% average weekly change). Earnings are forecast to decline by an average of 11% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (129% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.98m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$11m net loss next year). Anuncio • May 16
Endra Life Sciences Inc. Announces Impairment Charges for the First Quarter Ended March 31, 2024 ENDRA Life Sciences Inc. announced impairment charges for the first quarter ended March 31, 2024. For the period, the company announced fixed assets write off of $8,808. Anuncio • May 11
ENDRA Life Sciences Inc. Provides Earnings Guidance for the Quarter Ended March 31, 2024 ENDRA Life Sciences Inc. provided earnings guidance for the quarter ended March 31, 2024. The company expects no revenue for the quarter ended March 31, 2024 and did not have any revenue for the quarter ended March 31, 2023. The company expects to record a net loss of approximately $2.8 million for the quarter ended March 31, 2024, compared to a net loss of approximately $2.9 million for the quarter ended March 31, 2023. Anuncio • May 09
ENDRA Life Sciences Inc. to Report Q1, 2024 Results on May 14, 2024 ENDRA Life Sciences Inc. announced that they will report Q1, 2024 results After-Market on May 14, 2024 Anuncio • May 04
Endra Life Sciences Receives Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital Market Under Nasdaq Marketplace Rule 5550(a)(2) On May 3, 2024, ENDRA Life Sciences Inc. (the ‘Company’) received a notification letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that, because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company no longer meets the minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Marketplace Rule 5550(a)(2), requiring a minimum bid price of $1.00 per share (the ‘Minimum Bid Price Requirement’). The notification has no immediate effect on the listing of the Company’s common stock. In accordance with Nasdaq Marketplace Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from May 3, 2024, or until October 30, 2024, to regain compliance with the Minimum Bid Price Requirement. If at any time before October 30, 2024, the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the Minimum Bid Price Requirement. The notification letter also disclosed that in the event the Company does not regain compliance with the Minimum Bid Price Requirement by October 30, 2024, the Company may be eligible for additional time. To qualify for additional time, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days to regain compliance. However, if it appears to the staff of Nasdaq (the ‘Staff’) that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the Staff would notify the Company that its securities will be subject to delisting. In the event of such notification, the Company may appeal the Staff’s determination to delist its securities, but there can be no assurance the Staff would grant the Company’s request for continued listing. The Company intends to continue actively monitoring the bid price for its common stock between now and October 30, 2024 and will consider available options to resolve the deficiency and regain compliance with the Minimum Bid Price Requirement. New Risk • Apr 30
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Earnings are forecast to decline by an average of 8.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.12m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$12m net loss in 2 years). Anuncio • Apr 04
ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $6.2 million. ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $6.2 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Mar 28
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.05m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 3.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (248% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.05m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). Share price has been volatile over the past 3 months (13% average weekly change). Anuncio • Mar 22
ENDRA Life Sciences Inc. to Report Q4, 2023 Results on Mar 28, 2024 ENDRA Life Sciences Inc. announced that they will report Q4, 2023 results After-Market on Mar 28, 2024 Anuncio • Feb 21
ENDRA Life Sciences Inc. Welcomes the Adoption of the ICD-10 K76.0 Code for the Diagnosis of Non-Alcoholic Fatty Liver Disease ENDRA Life Sciences Inc. welcomes the adoption of the ICD-10 K76.0 code for the diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD). This pivotal update supports recent important advancements in the field of liver disease to underscore the increasing recognition of NAFLD's impact on global health by insurers and healthcare providers alike. ENDRA’s TAEUS system has received a CE mark in the European Union and is the subject of a De Novo request that is pending before the U.S. Food and Drug Administration (FDA). The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is a global coding system used to indicate a diagnosis for reimbursement purposes. These codes are issued by the World Health Organization (WHO) and are used to show payers why a particular service was medically necessary. The inclusion of NAFLD under the ICD-10 K76.0 code facilitates standardized billing for its diagnosis. It is applicable across the U.S., Europe and other regions, and promotes consistency in medical documentation and insurance processes. The U.S. Centers for Medicare & Medicaid Services (CMS) also utilizes ICD-10 codes for claims payment adjudication and reimbursement of contracted providers. ENDRA believes the issuance of the ICD-10 K76.0 code specifically for NAFLD measurement represents a significant opportunity for innovation in liver health diagnostics as healthcare providers now have a clearer pathway to integrate advanced diagnostic technologies. This encourages the adoption of methods such as ENDRA's TAEUS liver fat measurement system or service, thereby improving patient access to essential healthcare services and emphasizing the importance of early detection and management of liver diseases. Anuncio • Feb 15
ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $6.2 million. ENDRA Life Sciences Inc. has filed a Follow-on Equity Offering in the amount of $6.2 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering New Risk • Jan 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.30m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 3.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (168% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.30m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (137% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$7.26m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). Share price has been volatile over the past 3 months (12% average weekly change). Anuncio • Nov 08
ENDRA Life Sciences Inc. to Report Q3, 2023 Results on Nov 14, 2023 ENDRA Life Sciences Inc. announced that they will report Q3, 2023 results After-Market on Nov 14, 2023 Anuncio • Aug 15
ENDRA Life Sciences Submits De Novo Request for its TAEUS System Liver Fat Application to the U.S. FDA ENDRA Life Sciences Inc. announced the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system. The TAEUS system is ENDRA's proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD). The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction. The study data yielded a sensitivity of 90%. TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78. Anuncio • Aug 03
ENDRA Life Sciences Inc. to Report First Half, 2023 Results on Aug 14, 2023 ENDRA Life Sciences Inc. announced that they will report first half, 2023 results on Aug 14, 2023 Anuncio • Jul 26
ENDRA Life Sciences Inc., Annual General Meeting, Aug 09, 2023 ENDRA Life Sciences Inc., Annual General Meeting, Aug 09, 2023, at 10:00 US Eastern Standard Time. New Risk • Jul 25
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.73m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$12m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (137% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.73m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$13m net loss next year). Major Estimate Revision • Jun 01
Consensus revenue estimates decrease by 90%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$1.00m to US$100.0k. EPS estimate increased from -US$4.13 to -US$2.09 per share. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target down from US$30.00 to US$20.00. Share price was steady at US$1.47 over the past week. Anuncio • May 25
ENDRA Life Sciences Inc., Annual General Meeting, Jul 06, 2023 ENDRA Life Sciences Inc., Annual General Meeting, Jul 06, 2023. Agenda: To elect the five nominees to the board of directors nominated by the board of directors; to hold an advisory vote on executive compensation; to hold an advisory vote on frequency of future advisory votes on executive compensation; to ratify the appointment of rbsm llp as our independent registered public accounting firm for 2023; and to transact such other business as may properly come before the annual meeting and any adjournments or postponements thereof. Anuncio • May 05
ENDRA Life Sciences Inc. to Report Q1, 2023 Results on May 15, 2023 ENDRA Life Sciences Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 15, 2023 Board Change • May 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 2 highly experienced directors. Independent Director Lou Basenese was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Major Estimate Revision • Mar 29
Consensus revenue estimates increase by 57%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$5.85m to US$9.20m. EPS estimate fell from -US$3.00 to -US$4.13 per share. Medical Equipment industry in the US expected to see average net income growth of 14% next year. Consensus price target up from US$92.50 to US$100.00. Share price fell 15% to US$2.68 over the past week. Anuncio • Dec 26
ENDRA Life Sciences Inc. Announces Resignation of Renaud Maloberti as Chief Commercial Officer, Effective January 13, 2023 ENDRA Life Sciences Inc. announced that on December 21, 2022, Renaud Maloberti notified the Company of his resignation as the Company’s Chief Commercial Officer, effective January 13, 2023. Mr. Maloberti’s resignation is not in connection with any disagreement relating to the Company’s operations, policies, or practices. Major Estimate Revision • Nov 23
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$850.0k to US$700.0k. EPS estimate unchanged from -US$0.22 per share at last update. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target down from US$4.75 to US$4.63. Share price fell 9.2% to US$0.16 over the past week. Anuncio • Nov 10
ENDRA Life Sciences Inc. to Report Q3, 2022 Results on Nov 14, 2022 ENDRA Life Sciences Inc. announced that they will report Q3, 2022 results After-Market on Nov 14, 2022 Anuncio • Sep 30
ENDRA Life Sciences Inc. Plans to Submit De Novo Request to U.S. FDA for Its TAEUS System ENDRA Life Sciences Inc. and Thermo Acoustic Enhanced UltraSound (TAEUS®), announced an update to its plan to submit a De Novo request for the TAEUS system to the U.S. Food and Drug Administration (FDA). The TAEUS system is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). TAEUS is already approved for sale in countries that recognize the CE mark, including those in the European Union. The De Novo request provides a pathway in the United States for an entirely new product classification and, if granted, promises to strengthen TAEUS’ competitive position with its distinctive, patent-protected capabilities as a non-invasive point-of-care tool to characterize NAFLD, which impacts over one billion people globally. Major Estimate Revision • Sep 15
Consensus revenue estimates fall by 39% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$1.40m to US$850.0k. Forecast losses increased from -US$0.22 to -US$0.22 per share. Medical Equipment industry in the US expected to see average net income growth of 11% next year. Consensus price target down from US$5.00 to US$4.75. Share price rose 14% to US$0.36 over the past week. Price Target Changed • Sep 08
Price target decreased to US$4.75 Down from US$5.25, the current price target is an average from 2 analysts. New target price is 1,402% above last closing price of US$0.32. Stock is down 83% over the past year. The company is forecast to post a net loss per share of US$0.22 next year compared to a net loss per share of US$0.28 last year. Anuncio • Aug 05
ENDRA Life Sciences Inc. to Report Q2, 2022 Results on Aug 15, 2022 ENDRA Life Sciences Inc. announced that they will report Q2, 2022 results After-Market on Aug 15, 2022 Major Estimate Revision • Jun 07
Consensus revenue estimates fall by 21% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$1.40m to US$1.10m. Forecast losses increased from -US$0.19 to -US$0.20 per share. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target down from US$5.25 to US$5.00. Share price was steady at US$0.23 over the past week. Major Estimate Revision • May 19
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$0.26 to -US$0.19 per share. Revenue forecast unchanged from US$1.40m at last update. Medical Equipment industry in the US expected to see average net income growth of 16% next year. Consensus price target of US$5.25 unchanged from last update. Share price rose 21% to US$0.23 over the past week. Price Target Changed • Apr 27
Price target decreased to US$5.25 Down from US$6.13, the current price target is an average from 2 analysts. New target price is 1,863% above last closing price of US$0.27. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$0.27 next year compared to a net loss per share of US$0.28 last year. Major Estimate Revision • Apr 08
Consensus revenue estimates fall by 79% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$6.60m to US$1.40m. Forecast losses increased from -US$0.20 to -US$0.26 per share. Medical Equipment industry in the US expected to see average net income growth of 19% next year. Consensus price target down from US$6.13 to US$5.63. Share price fell 15% to US$0.32 over the past week. Price Target Changed • Apr 07
Price target decreased to US$5.63 Down from US$6.25, the current price target is an average from 2 analysts. New target price is 1,159% above last closing price of US$0.45. Stock is down 83% over the past year. The company is forecast to post a net loss per share of US$0.20 next year compared to a net loss per share of US$0.28 last year. Anuncio • Feb 11
ENDRA Life Sciences Inc. Provides Update on U.S. Regulatory Strategy for its TAEUS® System ENDRA Life Sciences Inc. announced it will build on the content of its completed 510(k) application and pursue the De Novo pathway for its TAEUS System, which is intended to characterize fatty liver tissue as a means to non-invasively assess and monitor Non-Alcoholic Fatty Liver Disease (NAFLD). ENDRA’s updated regulatory strategy is the result of a tremendous amount of productive dialogue with the U.S. Food and Drug Administration (FDA), which led to a clearer understanding of the path forward to achieve ENDRA’s U.S. market claims for the TAEUS System. While ENDRA could continue to pursue its 510(k) application, ENDRA now believes that the potential resulting 510(k) market claims may understate the TAEUS System’s clinical and commercial value. This is particularly so when ENDRA considers the remaining effort to demonstrate 510(k) predicate equivalency compared with the effort involved in the De Novo pathway. For a similar investment of time and effort, ENDRA believes it can achieve a stronger market position through the De Novo process with TAEUS-optimized market claims compared with the 510(k) approach. Unlike a 510(k) clearance in which FDA determines “substantial equivalence” between a new product and another commercially available product with the same intended use and safety and efficacy profile (e.g., Ultrasonic imaging systems), the De Novo process provides a pathway for ENDRA to set the bar for an entirely new product classification. Further, this regulatory path will showcase TAEUS’ distinctive capabilities and will highlight TAEUS as being unique and novel, thereby strengthening TAEUS’ competitive position when it becomes available for sale in the U.S. ENDRA’s De Novo submission will involve the following key steps: Leveraging substantial portions of ENDRA’s completed 510(k) submission, which encompasses many of the same elements as the intended De Novo submission, including safety and efficacy data. Customizing TAEUS’ proprietary testing methods into “special controls,” which will become requirements for future product submissions. This is expected to accelerate 510(k) submissions of future generations of TAEUS products while creating market-entry barriers for competitive products. Adding limited confirmatory clinical data from a subset of ENDRA’s existing clinical evaluation sites, which is expected to be available in 2022. Price Target Changed • Nov 16
Price target increased to US$6.50 Up from US$6.00, the current price target is an average from 2 analysts. New target price is 389% above last closing price of US$1.33. Stock is up 64% over the past year. The company is forecast to post a net loss per share of US$0.30 next year compared to a net loss per share of US$0.63 last year. Recent Insider Transactions • Aug 28
Independent Director recently sold US$92k worth of stock On the 26th of August, Louis Basenese sold around 50k shares on-market at roughly US$1.83 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$123k more than they bought in the last 12 months. Price Target Changed • Aug 24
Price target increased to US$6.25 Up from US$5.75, the current price target is an average from 2 analysts. New target price is 209% above last closing price of US$2.02. Stock is up 137% over the past year. Major Estimate Revision • May 24
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 expected loss increased from -US$0.24 to -US$0.27 per share. Revenue forecast of US$500.0k unchanged since last update. Medical Equipment industry in the US expected to see average net income growth of 35% next year. Consensus price target of US$5.75 unchanged from last update. Share price rose 14% to US$2.26 over the past week. Anuncio • Mar 18
ENDRA Life Sciences Inc. to Report Q4, 2020 Results on Mar 25, 2021 ENDRA Life Sciences Inc. announced that they will report Q4, 2020 results After-Market on Mar 25, 2021 Is New 90 Day High Low • Jan 09
New 90-day high: US$0.92 The company is up 29% from its price of US$0.72 on 09 October 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 9.0% over the same period. Anuncio • Dec 18
ENDRA Life Sciences Inc. has completed a Follow-on Equity Offering in the amount of $5.0001 million. ENDRA Life Sciences Inc. has completed a Follow-on Equity Offering in the amount of $5.0001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,143,000
Price\Range: $0.7 Is New 90 Day High Low • Dec 15
New 90-day high: US$0.90 The company is up 14% from its price of US$0.79 on 15 September 2020. The American market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Nov 28
New 90-day high: US$0.85 The company is up 3.0% from its price of US$0.82 on 28 August 2020. The American market is up 6.0% over the last 90 days, indicating the company underperformed over that time. However, its price trend is similar to the Medical Equipment industry, which is also up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Major Estimate Revision • Nov 24
Analysts update estimates The company's losses in 2020 are expected to improve with analysts raising their consensus EPS forecasts from -US$0.82 to -US$0.73. No change was made to the revenue estimate which at the last update was US$300.0k. The Medical Equipment industry in the US is expected to see an average net income growth of 19% next year. The consensus price target of US$5.08 was unchanged from the last update. Share price is down by 1.8% to US$0.80 over the past week. Price Target Changed • Oct 21
Price target raised to US$5.08 Up from US$4.38, the current price target is an average from 3 analysts. The new target price is 616% above the current share price of US$0.71. As of last close, the stock is down 37% over the past year. Is New 90 Day High Low • Oct 20
New 90-day low: US$0.70 The company is down 31% from its price of US$1.01 on 22 July 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment 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. Is New 90 Day High Low • Oct 03
New 90-day low: US$0.70 The company is down 22% from its price of US$0.90 on 02 July 2020. The American market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 11% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Anuncio • Aug 06
ENDRA Life Sciences Inc. to Report Q2, 2020 Results on Aug 14, 2020 ENDRA Life Sciences Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 14, 2020