10-Q: Monogram Technologies Inc. Reports Q1 2025 Results, Highlights FDA Clearance and India Clinical Trial Approval

Monogram Technologies Inc. announces its Q1 2025 financial results, including a net loss of $3.2 million, while also celebrating FDA 510(k) clearance for its mBs TKA System and regulatory approval for a clinical trial in India.

Summary

• Monogram Technologies Inc. reported a net loss of $3.2 million for the three months ended March 31, 2025, compared to a net loss of $3.5 million for the same period in 2024.
• The company's accumulated deficit as of March 31, 2025, was $71.4 million.
• Monogram did not generate any revenue from product sales in Q1 2025 or Q1 2024.
• Research and development expenses decreased by 6% to $2.258 million in Q1 2025, primarily due to the completion of the verification and validation phase of the Monogram mBs TKA System.
• Marketing and advertising expenses decreased by 63% to $44,000 in Q1 2025.
• General and administrative expenses remained relatively unchanged at $1.032 million.
• The company's cash and cash equivalents were $13.3 million as of March 31, 2025.
• Monogram received FDA 510(k) clearance for its Monogram mBs TKA System on March 17, 2025.
• The company obtained regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import its Monogram TKA System for a clinical trial.
• As of May 13, 2025, the company had sold 2,264,101 shares of Common Stock for total gross proceeds of $5.7 million in connection with its At-the-Market offering.
• The company issued to Pro-Dex a warrant exercisable into 298,122 shares of Series D Preferred Stock at an exercise price of $2.25 per share and a warrant exercisable into 85,705 shares of Common Stock at an exercise price of $2.67 per share in March 2025.

Sentiment

Score: 5

Explanation: The document presents a mixed sentiment. While the FDA clearance and India clinical trial approval are positive developments, the ongoing losses and dependence on external funding sources temper the overall outlook.

Positives

• FDA 510(k) clearance for the Monogram mBs TKA System allows the company to begin marketing the device.
• Regulatory approval from India's CDSCO for a clinical trial provides an opportunity to evaluate the Monogram TKA System in a real-world setting.
• The company has access to additional capital through existing agreements with B. Riley Principal Capital II, LLC and B. Riley Securities.
• Research and development expenses decreased, indicating potential efficiency gains in product development.
• The company successfully delivered a training version of the Monogram TKA System and hosted an Investigator Meeting in Ahmedabad, India.

Negatives

• The company continues to operate at a loss, with a net loss of $3.2 million for Q1 2025 and an accumulated deficit of $71.4 million.
• Monogram has not yet generated revenue from product sales.
• The company is facing a potential obligation to transfer consideration to Mount Sinai related to a licensing agreement, estimated at $1.5 million.
• Proposed Texas legislation could limit access to cadaveric specimens, potentially impacting testing and training activities.
• The company's auditors have raised concerns about its ability to continue as a going concern.

Risks

• The company's ability to continue as a going concern is dependent on its ability to generate revenues, raise capital, and/or obtain other financing.
• Macroeconomic and geopolitical factors, including tariffs and rising tensions in South Asia, could negatively impact the company's operations.
• Proposed Texas legislation on the use of unclaimed bodies for research could disrupt essential testing and training activities.
• The company is involved in a legal matter with a former investor.
• The company faces risks associated with technological or manufacturing difficulties, design issues, and competing technological and market developments.
• The company may be required to relinquish valuable rights to its technologies and/or future revenue streams, or grant licenses on terms that may not be favorable to us and/or may reduce the value of our Common Stock.

Future Outlook

Monogram intends to produce and market robotic surgical equipment and related software, orthopaedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. The company is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the systems advantages in real-world surgical settings. Monogram remains committed to a disciplined, long-term commercialization strategy and will take a measured and strategic approach to market adoption.

Management Comments

• Monogram will integrate recent upgrades to the cutting system and other system enhancements into the cleared mBs TKA System to further strengthen its competitiveness.
• Monogram is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience and demonstrate the systems advantages in real-world surgical settings.
• Monogram remains committed to a disciplined, long-term commercialization strategy and will take a measured and strategic approach to market adoption.

Industry Context

The company sees a significant and growing market opportunity for an active cutting robotic system that does not utilize haptic controls. The company believes the patent landscape for haptic control and the widespread adoption of products like the Mako Robotic Arm Assisted Surgery System developed by Stryker Corporation could be favorable for next-generation active cutting robots like Monograms mBs TKA System, which is being designed to efficiently resect bone without utilizing haptic controls.

Comparison to Industry Standards

• The document mentions Stryker's Mako Robotic-Arm Assisted Surgery System as a widely adopted product in the orthopedic robotics market.
• Monogram's mBs TKA System is being designed to efficiently resect bone without utilizing haptic controls, differentiating it from systems like Mako.
• The company is targeting a market for active cutting robotic systems, which it believes is a significant and growing opportunity.

Legal Proceedings

• Following our listing on Nasdaq, a former investor filed suit against the Company and its Transfer Agent in July 2023 in New York County Supreme Court.
• Both the Company and our Transfer Agent believe the claim is without merit and are seeking dismissal of the action, most recently filing a Reply Memorandum of Law in Support of Renewed Motion to Dismiss on February 13, 2024.

Stakeholder Impact

• Shareholders: The company's ongoing losses and potential dilution from future equity offerings could negatively impact shareholder value.
• Employees: The company's ability to continue as a going concern is dependent on its ability to raise capital, which could impact job security.
• Customers: The FDA clearance and clinical trial provide a pathway to commercialization, potentially benefiting patients in the future.
• Suppliers: The company's future capital requirements will depend on establishing and maintaining supply relationships with third parties.

Next Steps

• Monogram will integrate recent upgrades to the cutting system and other system enhancements into the cleared mBs TKA System.
• The company is focused on initial placements with key surgeon KOLs in strategic geographies to establish clinical experience.
• Monogram will continue training surgeons and hospital personnel in preparation for trial initiation in India.
• Monogram will deploy full-time employees to India to support surgeon training and clinical trial execution.
• The company anticipates that patient enrollment in the India clinical trial will start shortly, with the first surgeries within 90 business days.

Key Dates

Keywords

Monogram Technologies, mBs TKA System, FDA Clearance, Clinical Trial, Orthopedic Surgery, Robotics, AI, Financial Results, Series D Preferred Stock, Common Stock, B. Riley, India, Shalby Limited