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Monogram Orthopaedics (MGRM) - 2024 Q2 - Quarterly Report
MGRMMonogram Orthopaedics (MGRM)2024-08-15 20:32
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Regulatory Filings and Approvals - Monogram Technologies Inc. submitted a 510(k) premarket filing for the mBôs TKA System on July 19, 2024, with an FDA decision expected within 90 days[41]. - The Company received comprehensive feedback from the FDA on its Q1 2023 presubmission request, which is expected to aid in the 510(k) submission process[41]. - Monogram's mBôs TKA System is designed to efficiently resect bone without utilizing haptic controls, positioning it favorably in the market[55]. Financial Performance - The Company did not generate any sales during the six months ended June 30, 2024 or 2023, and does not anticipate additional sales before initiating a clinical study and obtaining regulatory approvals[60]. - The Company reported a net loss of 3,537,457forthethreemonthsendedJune30,2024,representinga32.43,537,457 for the three months ended June 30, 2024, representing a 32.4% improvement compared to a net loss of 5,236,541 for the same period in 2023[68]. - The company reported a net loss of approximately 7.0millionforthesixmonthsendedJune30,2024,withcashusedinoperatingactivitiesamountingto7.0 million for the six months ended June 30, 2024, with cash used in operating activities amounting to 6,477,911[80]. Capital Raising and Stock Offerings - The Company has sold 360,960 units from the Series D Preferred Stock Offering, generating total gross proceeds of 812,160[47].−UndertheAtMarketCommonStockOffering,Monogramhassold31,558sharesofCommonStock,resultingingrossproceedsof812,160[47]. - Under the At Market Common Stock Offering, Monogram has sold 31,558 shares of Common Stock, resulting in gross proceeds of 82,378.21 as of August 13, 2024[52]. - The Company plans to raise additional capital through various financing options, including a Common Stock Purchase Agreement allowing the sale of up to 20 million in shares[71]. Expenses and Liabilities - Research and development (R&D) expenses decreased by 18% to 2,425,629 for the three months ended June 30, 2024, and by 2% to 4,832,383forthesixmonthsendedJune30,2024comparedtothesameperiodsin2023[61].−Totaloperatingexpensesdecreasedby374,832,383 for the six months ended June 30, 2024 compared to the same periods in 2023[61]. - Total operating expenses decreased by 37% to 3,633,523 for the three months ended June 30, 2024, and by 25% to 7,243,683forthesixmonthsendedJune30,2024comparedtotherespectiveperiodsin2023[61].−TheCompanyhadtotalliabilitiesof7,243,683 for the six months ended June 30, 2024 compared to the respective periods in 2023[61]. - The Company had total liabilities of 2,774,768 as of June 30, 2024, primarily consisting of vendor accounts payable of 1,668,043andaccruedliabilitiesof1,668,043 and accrued liabilities of 677,356[78]. Cash Position and Future Outlook - As of June 30, 2024, the Company had approximately 7.3millionincashonhand,largelyfromproceedsoftheRegACommonStockOfferingthatendedinMay2023[70].−Thecompanybelievesitsexistingcashandcashequivalentswillbesufficienttomeetanticipatedcashrequirementsforatleast12months[86].−Futurecapitalrequirementswilldependonvariousfactors,includingsupplyrelationships,technologicalchallenges,andregulatoryapprovals[86].CompanyBackgroundandChanges−MonogramTechnologieschangeditsnamefromMonogramOrthopedicInc.onMay15,2024,toreflectitsbroaderfocusontechnology[56].−Thecompanyisclassifiedasan"emerginggrowthcompany,"allowingittotakeadvantageofcertainreportingexemptionsuntilitnolongerqualifies[93].MarketandEconomicConditions−Inflationhasnotsignificantlyimpactedthecompany′sfinancialconditiontodate,butfutureeffectsremainuncertain[85].−Thecompanyhasnotyetgeneratedprofitsandisdependentonraisingcapitalthroughequityofferingsanddebtfinancingstosupportoperations[87].OtherFinancialActivities−Cashprovidedbyfinancingactivitiesduringthesameperiodwas7.3 million in cash on hand, largely from proceeds of the Reg A Common Stock Offering that ended in May 2023[70]. - The company believes its existing cash and cash equivalents will be sufficient to meet anticipated cash requirements for at least 12 months[86]. - Future capital requirements will depend on various factors, including supply relationships, technological challenges, and regulatory approvals[86]. Company Background and Changes - Monogram Technologies changed its name from Monogram Orthopedic Inc. on May 15, 2024, to reflect its broader focus on technology[56]. - The company is classified as an "emerging growth company," allowing it to take advantage of certain reporting exemptions until it no longer qualifies[93]. Market and Economic Conditions - Inflation has not significantly impacted the company's financial condition to date, but future effects remain uncertain[85]. - The company has not yet generated profits and is dependent on raising capital through equity offerings and debt financings to support operations[87]. Other Financial Activities - Cash provided by financing activities during the same period was 15,434,902 in 2023, while it was 206,341in2024,indicatingasignificantdecreaseinfinancing[84].−ThecompanyiscurrentlyindiscussionswithMountSinairegardingapotentialpaymentobligationof1206,341 in 2024, indicating a significant decrease in financing[84]. - The company is currently in discussions with Mount Sinai regarding a potential payment obligation of 1% of the fair market value if a "Significant Transaction" occurs, contingent on a valuation exceeding 150,000,000[79]. - Cash used in investing activities remained stable, primarily consisting of equipment purchases, with no significant changes between 2024 and 2023[83].