Monogram Orthopaedics (MGRM) - 2024 Q3 - Quarterly Report

Financial Performance - The Company reported a net loss of $5,034,501 for the three months ended September 30, 2024, an 80$995,660 for the same period in 2023 [66]. - For the nine months ended September 30, 2024, the net loss was $12,078,661, a 16$10,090,923 for the same period in 2023 [66]. - The Company incurred cash used in operating activities of $12,078,661 for the nine months ended September 30, 2024, compared to$10,090,923 for the same period in 2023 [81]. - The Company has an accumulated deficit of $63,708,186 as of September 30, 2024 [72]. Revenue and Sales - The Company did not make any sales during the nine months ended September 30, 2024 or 2023, and does not anticipate additional sales before initiating a clinical study and obtaining regulatory approvals [59]. Expenses - Total operating expenses increased by 37$5,147,122, while decreasing by 7% during the nine months ended September 30, 2024, totaling $12,390,803 [63]. - Research and development expenses decreased by 17$2,214,729 for the three months ended September 30, 2024, and by 7% to $7,047,112 for the nine months ended September 30, 2024 [60]. - Marketing and advertising expenses surged by 5,607$1,838,937 during the three months ended September 30, 2024, driven by a marketing campaign for the Series D Preferred Stock Offering [61]. - General and administrative expenses increased by 3% during the three months ended September 30, 2024, and by 11% during the nine months ended September 30, 2024, primarily due to higher insurance and regulatory compliance costs [62]. Cash and Financing - As of September 30, 2024, the Company had approximately $16.6 million in cash on hand and working capital of approximately$16.1 million [67]. - Cash provided by financing activities for the nine months ended September 30, 2024, was $13,991,161, compared to$14,877,980 for the same period in 2023 [85]. - The Company has sold 292,726 shares of Common Stock to B. Riley Principal Capital, II LLC for gross proceeds of $961,245, leaving approximately$19 million worth of Common Stock available for sale [69]. - The Company plans to continue raising additional capital through various financing options, including equity and debt offerings [67]. Regulatory and Compliance - The Company submitted a 510(k) premarket filing to the FDA for its semi-active mBôs TKA System, which is currently under review [51]. - Monogram anticipates holding an issue-specific meeting with the FDA by December 2024 to address the Additional Information Request received [52]. - The Company has 180 days from receiving the AIR to respond with the requested information, which may include clinical data [53]. Liabilities and Obligations - Total liabilities as of September 30, 2024, were $2.8 million, primarily consisting of vendor accounts payable of$1.5 million [79]. - The Company is obligated to issue Pro-Dex a warrant exercisable into 298,122 shares of Series D Preferred Stock at an exercise price of $2.25 per share due to exceeding$5 million in gross proceeds from offerings [78]. Going Concern - The company's ability to continue as a going concern depends on its ability to generate revenues and raise capital to meet current and future obligations [95]. - The company may remain an "emerging growth company" for up to five years starting January 26, 2022, unless the market value of its Common Stock held by non-affiliates exceeds $700 million [98]. - The company is subject to less rigorous public reporting requirements as an "emerging growth company," potentially providing shareholders with less information than more mature public companies [99].