Monogram Orthopaedics (US:MGRM)2025-08-15 20:17Regulatory Approvals and Clinical Trials - Monogram Technologies Inc. has received FDA 510(k) clearance for its Monogram mBôs™ TKA System, allowing the company to market the device, which is a significant milestone for future revenue generation [84]. - The company has initiated a clinical trial for its Monogram TKA System, which includes 102 total knee replacement procedures across multiple sites in India [89]. - Monogram Technologies has filed several patents for its active control scheme, which is currently under review, positioning the company favorably in the orthopedic robotics market [90]. Financial Performance - The company reported no product sales for the three and six months ended June 30, 2025, consistent with the same periods in 2024 [91]. - The company reported a net loss of $5.4 million for the three months ended June 30, 2025, a 54% increase from the $3.5 million net loss in the same period of 2024 [99]. - For the six months ended June 30, 2025, the net loss was $8.6 million, representing a 23% increase compared to the $7.0 million net loss during the same period in 2024 [99]. - As of June 30, 2025, the company had approximately $12.8 million in cash and working capital of approximately $7.2 million [100]. - The company recorded total liabilities of $6.4 million as of June 30, 2025, which included $4.0 million related to the Termination Agreement with Mount Sinai [111]. - Cash used in operating activities for the six months ended June 30, 2025, was $4.6 million, a decrease from $6.5 million in the same period of 2024 [112]. - The company raised approximately $1.0 million from the sale of 292,726 shares of Common Stock to B. Riley Principal Capital II LLC during the six months ended June 30, 2025 [104]. - The company has an accumulated deficit of $77.0 million as of June 30, 2025 [107]. Operating Expenses - Total operating expenses decreased by 15% to $3.071 million for the three months ended June 30, 2025, compared to $3.634 million in 2024 [92]. - Research and development expenses decreased by 7% to $2.257 million for the three months ended June 30, 2025, primarily due to the completion of the verification and validation phase of the Monogram mBôs™ TKA System [92]. - Marketing and advertising expenses decreased by 54% to $42,000 for the three months ended June 30, 2025, compared to $92,000 in 2024 [92]. - General and administrative expenses decreased by 31% to $772,000 for the three months ended June 30, 2025, compared to $1.116 million in 2024 [97]. Mergers and Agreements - Monogram Technologies has entered into a merger agreement with Zimmer Biomet, with a cash consideration of $4.04 per share for common stock [76]. - The company entered into a termination agreement with Mount Sinai, paying $500,000 and issuing 35,000 shares of Series E Preferred Stock as part of the agreement [81]. - The company entered into a Merger Agreement with Zimmer Biomet on July 11, 2025, which restricts the issuance of equity or equity-linked securities without prior consent [102]. - The company expects to rely on a Loan Agreement with Zimmer Biomet for up to $15 million if the merger is not completed as anticipated [103]. Company Classification and Reporting - The company may remain an "emerging growth company" for up to five years starting from January 26, 2022, unless the market value of its Common Stock held by non-affiliates exceeds $700 million [123]. - As an "emerging growth company," the company benefits from less rigorous public reporting requirements compared to more mature public companies [124]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [125]. Estimates and Projections - The company anticipates that existing cash resources will be sufficient to fund operations through the expected closing of the merger [118]. - The company is required to make significant estimates related to stock-based compensation and income tax valuation allowance in its financial statements [121].