Endra Life Sciences Inc Stock Price, News & Analysis

ENDRA Life Sciences (NASDAQ: NDRA) announced a strategic pivot for its TAEUS® (Thermo-Acoustic Enhanced UltraSound) system, focusing on early detection and management of metabolic diseases in patients using GLP-1 drugs and MASH therapies.

The company is repositioning TAEUS as a biomarker solution for steatotic liver disease (SLD), which affects over 2 billion people globally and one-third of the U.S. population. The new strategy targets four key markets: pharmaceutical companies, concierge medical practices, bariatric clinics, and primary care practices.

Key initiatives include: redesigning TAEUS to be more accurate and user-friendly with AI features, introducing a subscription-based sales model with no upfront costs, and expanding applications beyond liver health to include temperature monitoring for ablation therapies and vascular perfusion.

ENDRA Life Sciences (NASDAQ: NDRA) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its TAEUS Liver device development. The company has implemented a new strategy focusing on TAEUS as a biomarker solution for metabolic diseases in GLP-1 drug patients.

Key operational highlights include: acquiring data from over 110 subjects across new evaluation sites, implementing a revised FDA De Novo submission strategy with a planned multicenter study of approximately 250 subjects, and significant cost reductions bringing monthly operational cash burn down to $0.5 million in Q4 2024 from $0.8 million in 2023.

Financial results show Q4 2024 net loss of $4.2 million (vs $1.5 million in Q4 2023), including a $2.3 million non-cash inventory charge. Full-year 2024 saw reduced cash burn at $7.4 million (vs $9.5 million in 2023), with a net loss of $11.5 million. Cash position stood at $3.2 million as of December 31, 2024.

ENDRA Life Sciences (NASDAQ: NDRA) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received confirmation from Nasdaq Listing Qualifications Department on November 21, 2024, verifying its compliance with Listing Rule 5550(a)(2). This development allows ENDRA to maintain its Nasdaq listing and focus on implementing its new transformational business strategies, as previously discussed during their August conference call.

ENDRA Life Sciences (NASDAQ: NDRA) reported Q3 2024 financial results and business updates. The company accelerated enrollment in its global multisite pilot study, with nearly 40 subjects enrolled in the past two months. Operating expenses decreased 52% to $1.5 million compared to Q3 2023, achieving $3.1 million in annualized savings. Net loss was $2.4 million, including a $911,000 non-cash charge. Cash position stood at $4.7 million as of September 30, 2024.

The company enhanced its TAEUS platform with AI and machine learning features, expanded its patent portfolio to 82 issued patents globally, and activated a system at LMU University Hospital in Germany for clinical evaluation.

ENDRA Life Sciences (NASDAQ: NDRA) announced the acceptance of a poster presentation at The Liver Meeting 2024, showcasing their TAEUS technology's capability to measure liver fat in high-BMI patients. The study demonstrates TAEUS's ability to obtain liver fat measurements in patients with BMI over 35, including cases where BMI exceeded 40 and the liver was more than 40mm below the skin surface. The presentation, titled 'Noninvasive assessment of steatotic liver disease in individuals with class 2 and class 3 obesity,' will be presented at the AASLD conference in San Diego from November 15-19, 2024.

ENDRA Life Sciences (NASDAQ: NDRA) has been granted its 17th European patent (EP4247282) for a novel method of monitoring tissue temperature during minimally invasive thermal surgical procedures using their TAEUS® system. The patent relates to monitoring tissue ablation and enables integration with existing ablation systems. The technology is applicable to microwave and radiofrequency thermal ablation procedures, which are growing globally as less invasive alternatives to open surgery. This addition brings ENDRA's global intellectual property portfolio to 82 issued patents across key markets including the United States, Europe, and China.

ENDRA Life Sciences (NASDAQ: NDRA) has initiated a post-CE mark clinical study for its TAEUS liver system at LMU University Hospital in Munich, Germany. The study aims to assess TAEUS' liver fat measurement capabilities against the gold standard MRI-PDFF test. LMU researchers plan to present findings at future medical congresses and publish in peer-reviewed journals.

This collaboration is expected to:

• Build upon ENDRA's growing portfolio of clinical data
• Support the company's FDA De Novo submission targeted for mid-2025
• Support the adoption of TAEUS technology as a reliable and accurate biomarker for liver fat
• Mark a strategic entry into Germany's healthcare market, the largest in Europe

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has been granted an extension by Nasdaq to regain compliance with the $1.00 bid price requirement for continued listing on The Nasdaq Capital Market. The company now has until November 20, 2024 to evidence a closing bid price of at least $1.00 per share for a minimum of 10 consecutive trading sessions. This extension does not immediately affect ENDRA's listing or trading status, and its stock will continue to trade under the symbol 'NDRA'.

Additionally, ENDRA reported that 91% of the Series B Warrants issued in their June 2024 public offering have been exercised, resulting in the issuance of 15,831,864 new shares of common stock. This brings the company's total outstanding common shares to 17,280,655.

ENDRA Life Sciences (NASDAQ: NDRA) reported Q2 2024 financial results and provided a business update. Key highlights include:

1. New executive team: Alexander Tokman appointed as acting CEO, along with new CFO and Head of Regulatory and Clinical Affairs.

2. Clinical and regulatory progress: Advanced U.S. FDA process, initiated new pilot clinical trials, and expanded patent portfolio to 81 issued patents globally.

3. Financial updates: Raised $8.0 million in a public offering and reduced annualized operating expenses by $3.1 million.

4. Q2 2024 financials: Operating expenses decreased to $2.2 million from $3.0 million in Q2 2023. Cash and cash equivalents were $6.4 million as of June 30, 2024.

The company is prioritizing clinical data collection for a new De Novo FDA filing and revisiting its go-to-market strategy for TAEUS technology.