ENDRA Life Sciences has recently made significant changes in its leadership team, with the appointment of Alexander Tokman as the acting CEO. Tokman, a board member with over 24 years of global commercial leadership experience, brings a wealth of knowledge to the role. Additionally, the company has welcomed two industry veterans to key positions in regulatory and clinical affairs, as well as finance. Richard Jacroux, the new Chief Financial Officer, boasts over 20 years of financial management and accounting experience, having previously served as CFO at several technology companies. Ziad Rouag, the Head of Regulatory and Clinical Affairs, brings more than two decades of experience in the medical device industry, specializing in clinical operations and regulatory affairs for startups and high-growth businesses.
The focus for ENDRA Life Sciences in the recent quarter has been on advancing clinical and regulatory activities. The company made strides in the U.S. regulatory process by meeting with the U.S. Food and Drug Administration (FDA) at their headquarters in Maryland to demonstrate the TAEUS technology and review clinical and statistical plans. The meeting confirmed alignment on discussed topics and outlined the necessary steps for a successful regulatory outcome. To drive this process forward, ENDRA has brought on Mr. Rouag, an experienced regulatory and clinical leader.
Furthermore, new pilot clinical trials were initiated at two clinical sites in North America, with an additional trial expected to commence in Europe. These trials aim to generate data that demonstrate the value of the TAEUS system to clinical users. ENDRA plans to utilize the data from these sites to showcase the system’s performance to the FDA before initiating the De Novo pivotal study.
In addition to its clinical and regulatory efforts, ENDRA has expanded its intellectual property portfolio, now boasting 81 issued patents globally. During the second quarter of 2024, the company was granted five additional patents, including three in Europe and two in China. This robust intellectual property portfolio provides protection for the TAEUS system and opens up opportunities for exploring licensing agreements for indications beyond its core focus.
On the financial front, ENDRA successfully raised $8.0 million in a public offering, bolstering its capital reserves. The company also took steps to significantly reduce operating expenses by restructuring operations, resulting in a $3.1 million reduction in annualized expenses compared to the prior year’s second quarter.
Looking ahead, Alexander Tokman, the acting CEO, emphasized the company’s priority of securing clinical data to support a new De Novo regulatory filing with the FDA. Simultaneously, ENDRA is revisiting its go-to-market strategy for TAEUS to ensure a focus on promising vertical markets. The company is also working on formalizing its longer-term business strategy and refining its vision, all while maintaining a keen eye on operating expenses.
In terms of financial performance, operating expenses in the second quarter of 2024 totaled $2.2 million, down from $3.0 million in the same period in 2023. The decrease was primarily attributed to lower research and development expenses as resources were shifted towards clinical activities and product optimization. As of June 30, 2024, ENDRA reported cash and cash equivalents of $6.4 million, with an additional $7.3 million raised in net proceeds through a public offering in June 2024.
ENDRA Life Sciences will be hosting a conference call and webcast to discuss its financial results, recent corporate developments, and answer questions from stakeholders. Participants can pre-register for the call to receive a unique PIN for immediate access or dial in using the provided numbers.
In conclusion, ENDRA Life Sciences is making significant strides in its clinical, regulatory, and financial endeavors. With a focus on securing clinical data, expanding its intellectual property portfolio, and reducing operating expenses, the company is positioning itself for future growth and success in the medical device industry.
