Endra Life Sciences Inc Stock Price, News & Analysis

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.

ENDRA Life Sciences Inc. (NASDAQ: NDRA) has announced a 1-for-50 reverse stock split effective August 20, 2024. This move aims to increase the bid price of its common stock to regain compliance with Nasdaq's minimum bid price requirement. The split will reduce outstanding shares from approximately 72.4 million to 1.4 million, with authorized shares decreasing from 1 billion to 20 million. Trading will continue under the symbol 'NDRA' on a split-adjusted basis. Stockholders' fractional shares will be rounded up to the nearest whole share. The company's transfer agent, VStock Transfer, , will manage the process for stockholders of record, while those holding shares through brokers will have their positions adjusted automatically.

ENDRA Life Sciences (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), has rescheduled its second quarter conference call to August 22, 2024, at 4:30 p.m. Eastern time. The call was previously set for August 14, 2024. ENDRA will file its quarterly report on form 10-Q with the SEC as planned and issue a press release summarizing financial and operating results for Q2 2024 on the day of the call.

Participants can pre-register for the call using a provided link to receive a unique PIN for immediate access. Those unable to pre-register can dial (844) 868-8846 (U.S.) or (412) 317-5465 (International). A webcast will be available on ENDRA's Investor Relations page. A telephone replay will be accessible until August 29, 2024, and a webcast replay will be available shortly after the call.

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), announced significant leadership changes. Alexander Tokman, a board member with 24+ years of global commercial leadership experience, has been appointed as acting CEO, replacing Francois Michelon. The company also added two industry veterans to key roles: Ziad Rouag as Head of Regulatory and Clinical Affairs and Richard Jacroux as Chief Financial Officer.

Tokman brings extensive experience in driving revenue growth and implementing improved strategies for startups and established companies. He aims to focus on core regulatory and commercial activities to secure approval and launch ENDRA's patented technology. Rouag's expertise in regulatory affairs will support TAEUS's domestic regulatory process, while Jacroux's financial management experience will aid in scaling the business.

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), has announced its plans to report financial results for Q2 2024 on August 14, 2024, after the U.S. financial markets close. The company will host a conference call and webcast at 4:30 p.m. Eastern time to discuss the results, provide updates on recent corporate developments, and answer questions.

Participants are encouraged to pre-register for the call using a provided link, which will grant them immediate access with a unique PIN. Those unable to pre-register can dial in using specific U.S. and International numbers. A webcast of the call will be accessible through ENDRA's Investor Relations page. Both telephone and webcast replays will be available until August 21, 2024.

ENDRA Life Sciences (Nasdaq: NDRA) announced the pricing of an $8.0 million public offering. The offering includes 61,538,461 shares of common stock or pre-funded warrants, each paired with Series A and B Warrants. The Series A Warrants have an exercise price of $0.22 per share, while Series B Warrants offer an alternative cashless exercise option. The closing date is expected around June 5, 2024, pending customary conditions. Net proceeds will be used for working capital and general corporate purposes. Craig-Hallum is the sole placement agent. This offering follows an SEC-approved registration statement on Form S-1.

ENDRA Life Sciences (NASDAQ: NDRA), a pioneer in Thermo Acoustic Enhanced UltraSound (TAEUS®), announced a significant update following an in-person meeting with the FDA. The meeting focused on the clinical trial design of the TAEUS liver device, which is important for ENDRA's U.S. De Novo filing. ENDRA presented a detailed description of TAEUS technology and a synopsis of their clinical study, which spans a fat fraction range representative of steatotic liver disease in the U.S.

The company provided background clinical data and statistical analyses from 45 historical study participants. The meeting highlighted ENDRA's proposed pivotal clinical study and included a demonstration of the TAEUS procedure. Key ENDRA team members, including technical staff and biostatisticians, attended the meeting. The FDA's feedback was deemed constructive, and ENDRA plans to update its clinical study protocol and statistical plan for FDA submission. This close engagement aims to ensure alignment on the pivotal study design for a future De Novo submission.