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01/11 16:21
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reveals financial challenges, including a significant net loss, increased expenses, and a low cash position. While there are potential partnerships and regulatory progress, the failure to meet primary endpoints in trials and competitive market pressures raise concerns. The Q&A session shows management's vague responses on key issues, adding to uncertainty. Despite some positive aspects, such as modest financing and ongoing trials, the overall sentiment is negative due to financial instability and regulatory risks.
Total Expenses $2,700,000 (up $396,000 or 17.3% year-over-year) due to increased research and development expenses.
Research and Development Expense $1,500,000 (up $289,000 or 24.1% year-over-year) primarily due to costs associated with closing out the cardiac heart failure trial and starting enrollment in the new trial.
Selling, General and Administrative Expenses $1,200,000 (up $100,000 or 9.1% year-over-year) with expectations to track closely to 2024 levels.
Net Loss $2,700,000 (up $400,000 or 17.4% year-over-year) reflecting increased expenses.
Net Cash Used in Operations $1,600,000 (up $100,000 or 6.7% year-over-year) comparable to the previous year.
Cash and Cash Equivalents $949,000 at the end of the quarter, prior to a modest financing that brought in additional capital.
CARDI Amp Cell Therapy: Demonstrated safety and meaningful benefits for heart failure patients; potential impact on 1,000,000 Americans with heart failure.
Helix Biotherapeutics Delivery System: Preparing for submission for approval; expected to be the first approved transcendental cardio biotherapeutic delivery system in the U.S.
MorphDNA Steerable Introducer Platform: Continuing to detail advantages to physicians and partners.
Market Expansion in Japan: Seeking approval for CARDI Amp cell therapy; potential to align with FDA pathways.
Electrophysiology Market: Greater than $10 billion per year; expanded to treat arrhythmias in ventricles.
Operational Efficiencies: Manufacturing clinical grade cells at a cost profile likely less than peers; minimal dilution financing chosen.
Business Development Strategy: Focusing on partnerships to create value; active discussions with large cap strategics.
Regulatory Risks: The company faces inherent uncertainties associated with developing new products and obtaining regulatory approvals, particularly with the FDA and Japan's PMDA.
Clinical Trial Risks: The ongoing CardiAmp heart failure trial did not hit its primary endpoint, introducing significant risks to the approval pathway ahead.
Market Competition: The company operates in a competitive market, particularly in the electrophysiology sector, which is growing rapidly and has established players.
Economic Factors: Potential impacts from tariffs and pricing policies, such as the most favored nation status, could affect reimbursement and market access.
Supply Chain Challenges: The company relies on some overseas manufacturing, which could be impacted by tariffs, although most production occurs domestically.
Financial Risks: The company reported a net loss of $2.7 million in Q1 2025, indicating ongoing financial pressures as they advance their therapeutic candidates.
CARDI Amp heart failure trial: Results demonstrated safety and meaningful benefits for heart failure patients. The priority is to share data with the FDA and Japan’s PMDA.
CardioM Heart Failure II trial: Actively enrolling patients to confirm results from the CARDI Amp therapy.
Helix Biotherapeutics delivery: Preparing for submission for approval, expected to be valued by therapeutic partners.
MorphDNA platform: Continuing to detail advantages to physicians and partners.
Business Development: Focusing on partnerships to create value across all four platforms: CardiAmp, Cardiallo, Helix, and MorphDNA.
R&D Expenses: Expected to increase modestly in 2025 as therapeutic candidates advance.
SG&A Expenses: Expected to track closely to 2024 levels.
Net Loss: Reported at $2.7 million in Q1 2025, compared to $2.3 million in Q1 2024.
Cash Position: Ended Q1 2025 with $949,000 before financing.
Future Milestones: Expecting significant milestones soon, including FDA submissions and trial enrollments.
Financing: Management chose to do a small financing at the market with minimum dilution to deliver on the milestones before us.
Cash and Cash Equivalents: The company ended the quarter with cash and cash equivalents totaling $949,000 before we did the modest financing and brought in some additional capital.
Net Loss: Our net loss was $2,700,000 in Q1 twenty twenty five compared to $2,300,000 in Q1 twenty twenty four.
Net Cash Used in Operations: Net cash used in operations was $1,600,000 for the first quarter of twenty twenty five comparable to the $1,500,000 recognized in the same quarter in 2024.
The earnings call shows mixed signals: a slight increase in revenue, reduced SG&A expenses, and a decrease in net loss for Q3, but an increase in net loss over nine months. The Q&A reveals positive progress in trials but lacks transparency in patient enrollment numbers. The strategic plan highlights potential partnerships and regulatory approvals, which could be positive. However, the absence of market cap data and the lack of immediate strong catalysts lead to a neutral outlook for short-term stock movement.
The earnings call reveals mixed signals. Financial performance shows increased net loss and cash usage, which are negative. However, there are ongoing advancements in trials and partnerships, which are positive. The Q&A highlights uncertainties around regulatory approvals and partnerships, but also potential growth opportunities. The neutral sentiment reflects this balance of positive developments against financial challenges and uncertainties.
The earnings call reveals financial challenges, including a significant net loss, increased expenses, and a low cash position. While there are potential partnerships and regulatory progress, the failure to meet primary endpoints in trials and competitive market pressures raise concerns. The Q&A session shows management's vague responses on key issues, adding to uncertainty. Despite some positive aspects, such as modest financing and ongoing trials, the overall sentiment is negative due to financial instability and regulatory risks.
The earnings call summary suggests a negative outlook due to several factors: increasing net losses, low cash reserves, and high financial risks. The Q&A section shows management's vague responses and lack of clarity on strategic timelines, which may raise investor concerns. Despite ongoing partnerships and potential regulatory approvals, the financial health and competitive pressures overshadow these positives. The market's reaction is likely negative due to financial instability and uncertainties in achieving key milestones.
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