Regulatory Approvals - Monogram Technologies Inc. received FDA 510(k) clearance for its Monogram mBôs™ TKA System on March 17, 2025, allowing the company to market the device[57]. Financial Performance - The company 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, reflecting a decrease in losses[68]. - The Company incurred a net loss of $3.2 million for the three months ended March 31, 2025, with an accumulated deficit of $71.4 million[73]. - Cash used in operating activities for the three months ended March 31, 2025, was $2.3 million, compared to $3.6 million for the same period in 2024[80][81]. Operating Expenses - Total operating expenses for the three months ended March 31, 2025, were $3.334 million, an 8% decrease from $3.610 million in the same period of 2024[63]. - Research and development expenses decreased by 6% to $2.258 million for the three months ended March 31, 2025, primarily due to the completion of the verification and validation phase of the Monogram mBôs™ TKA System[63]. - Marketing and advertising expenses decreased by 63% to $44,000 for the three months ended March 31, 2025, compared to $120,000 in the same period of 2024[65]. Cash and Capital Resources - The company had approximately $13.3 million in cash and working capital of approximately $12.1 million as of March 31, 2025[70]. - The Company expects its existing cash and cash equivalents, along with proceeds from financing deals, to meet anticipated cash requirements for at least 12 months[87]. - The Company has approximately $19.0 million worth of Common Stock available for sale under the Purchase Agreement with B. Riley Principal Capital II[71]. Equity and Financing - The Company sold 2,264,101 shares of Common Stock for total gross proceeds of $5.7 million through an equity offering program[72]. - The Company entered into a Common Stock Purchase Agreement allowing it to sell up to $20.0 million in shares to B. Riley Principal Capital II over a 24-month period[71]. - The Company has not yet generated profits and continues to rely on equity offerings and debt financings to support its operations[90]. Clinical Investigations - Monogram plans to conduct a 102-patient clinical investigation in India to evaluate the safety and effectiveness of the Monogram TKA System, with patient enrollment expected to start shortly[59]. - The company is focused on initial placements of its mBôs™ TKA System with key surgeon KOLs to establish clinical experience and demonstrate advantages in real-world settings[57]. Liabilities and Contingencies - As of March 31, 2025, the Company had total liabilities of $3.7 million, including trade accounts payable of $1.2 million and accrued liabilities of $650,000[77]. - The Company has a contingent liability estimated at $1.5 million related to a potential obligation to Mount Sinai under a licensing agreement[79]. Market and Economic Factors - Monogram is monitoring macroeconomic and geopolitical factors, including new tariffs and rising tensions in South Asia, which could impact future operations and costs[54]. Intellectual Property - The company has filed several patents around its active control scheme for robotic systems, which are currently under review[61]. Other Income - The Company received $82,000 from the exercise of warrants to purchase 20,054 shares of Common Stock during the three months ended March 31, 2025[75][84].
Monogram Orthopaedics (MGRM) - 2025 Q1 - Quarterly Report