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ENDRA Life Sciences Inc (NDRA) (Q1 2024) Earnings Call Transcript Highlights: Strategic ...

GuruFocus Research
·4-min read

  • Operating Expenses: Decreased to $2.8 million from $2.9 million in Q1 2023.

  • Research and Development Expenses: Decreased by approximately $350,000 year-over-year.

  • Sales and Marketing Expenses: Increased by approximately $57,000, mainly due to higher consulting fees.

  • General and Administrative Expenses: Increased by approximately $134,000, mainly due to higher professional fees.

  • Net Loss: $2.8 million or $0.26 per share in Q1 2024, compared to $2.9 million or $0.93 per share in Q1 2023.

  • Cash and Cash Equivalents: $1.1 million as of March 31, 2024.

  • Equity Financing: Raised $420,000 in gross proceeds from the sale of common stock and $77,000 from the exercise of warrants in Q1 2024.

Release Date: May 14, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • ENDRA Life Sciences Inc (NASDAQ:NDRA) has successfully activated new clinical research sites in target markets, enhancing the body of clinical evidence for their technology.

  • The company has installed its first payer system in the United Kingdom at King's College Hospital, marking a significant milestone in the U.K. market.

  • ENDRA Life Sciences Inc (NASDAQ:NDRA) is closely working with the FDA to align on clinical requirements for their TS system's de novo application, with a pre-submission meeting scheduled this quarter.

  • The company is leveraging accelerating market developments in liver disease detection and treatment to strengthen its position.

  • ENDRA Life Sciences Inc (NASDAQ:NDRA) is expanding its intellectual property portfolio, securing eight new patents this year, bringing the total to 80 issued patents worldwide.

Negative Points

  • The company reported a net loss of $2.8 million for the first quarter of 2024, indicating ongoing financial challenges.

  • Research and development expenses have decreased, which might impact the pace of innovation and development of new technologies.

  • General and administrative expenses have increased, mainly due to higher professional fees, adding to the financial burden.

  • The reliance on FDA approval for significant market expansions, such as the distribution agreement in Vietnam, poses a risk if regulatory approvals are delayed or not received.

  • ENDRA Life Sciences Inc (NASDAQ:NDRA)'s cash and cash equivalents were relatively low at $1.1 million as of March 31, 2024, which may necessitate further fundraising to sustain operations.

Q & A Highlights

Q: Can you discuss the significance of the new clinical sites in Europe and the U.S. for ENDRA Life Sciences? A: Francois Michelon, CEO, highlighted the importance of activating new clinical research sites in target markets to build a robust body of clinical evidence. This is crucial for demonstrating the clinical and economic value of ENDRA's technology to potential users in these markets.

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Q: What are the expected outcomes from the upcoming FDA pre-submission meeting? A: Michael Thornton, CTO, explained that the focus of the FDA pre-submission meeting would be on aligning clinical trial designs with FDA requirements. This alignment is essential for advancing regulatory submissions and ensuring the data from these trials meets the FDA's current standards.

Q: How does the recent FDA approval of a new drug therapy for NASH impact ENDRA Life Sciences? A: Francois Michelon, CEO, noted that the FDA's approval of new drug therapies for liver diseases like NASH underscores the growing need for precise diagnostic tools. ENDRA's technology could play a significant role in meeting this demand, given its potential for more accessible point-of-care diagnostics.

Q: What strategic moves is ENDRA making to leverage its intellectual property? A: Francois Michelon, CEO, mentioned that ENDRA is actively exploring collaborations and strategic pathways to expand the applications of its test platform beyond liver diagnostics. This includes engaging with patent advisory firms to manage and potentially license their intellectual property.

Q: What financial strategies is ENDRA implementing to manage its resources effectively? A: Irina Pestrikova, Senior Director of Finance, outlined that ENDRA is focused on managing its financial resources by optimizing expenses and exploring financing opportunities. This strategy is intended to support ongoing operations and progress the company's operational plans.

Q: Are there any plans for expansion into Asian markets, specifically beyond the existing agreements in Vietnam and Shanghai? A: Francois Michelon, CEO, stated that while ENDRA has foundational agreements in Vietnam and Shanghai, the primary focus is on succeeding in European and U.S. markets first. Expansion into other Asian markets will depend on the success and clinical evidence gathered from these initial markets.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.