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Monogram Orthopaedics (MGRM) - 2024 Q4 - Annual Report
2025-03-12 20:55
Financial Performance - Monogram Technologies reported revenue of $364,999 for the year ended December 31, 2023, from the sale of a single unit of robotic surgical equipment, with no product sales in 2024 anticipated before obtaining regulatory approvals[246]. - Revenue for 2024 was reported at $0, a decrease from $365,000 in 2023, indicating a decline of 100%[316]. - The company reported a net loss of $16.3 million in 2024, compared to a net loss of $13.7 million in 2023[256]. - Net loss for 2024 was $16,328,000, compared to a net loss of $13,745,000 in 2023, representing an increase in loss of 18.8%[316]. - Basic and diluted loss per common share improved to $(0.51) in 2024 from $(0.61) in 2023[316]. - The company has an accumulated deficit of $68.0 million as of December 31, 2024, highlighting ongoing financial challenges[345]. - Cash used in operating activities was $13.97 million for 2024, slightly higher than $13.54 million in 2023, indicating a 3.2% increase in cash outflow[345]. - The company experienced a $1.2 million charge for stock-based compensation in 2024, contributing to the cash used in operating activities[277]. Operating Expenses - Total operating expenses decreased by 13% from $17,633,000 in 2023 to $15,310,000 in 2024, with research and development expenses down 17% to $8,790,000[247]. - Operating expenses for marketing and advertising decreased by 30% from $2,994,000 in 2023 to $2,108,000 in 2024[247]. - General and administrative expenses increased by 9% in 2024 from 2023, mainly due to a full year of public company expenses, including insurance and regulatory compliance[251]. - Total operating lease expense for the year ended December 31, 2024 was $136,000, slightly down from $141,000 in 2023[391]. Cash and Capital - As of December 31, 2024, the company had approximately $15.7 million in cash and total stockholders' equity of $14.5 million, with working capital of approximately $14.8 million[257]. - Cash and cash equivalents increased to $15,658,000 in 2024 from $13,589,000 in 2023, an increase of 15.3%[314]. - The company anticipates that existing cash and cash equivalents will be sufficient to meet cash requirements for at least 12 months from the date of the annual report[294]. - The company raised $5.19 million from common stock issuances in 2024, down from $15.33 million in 2023, indicating a decrease of approximately 66.2%[345]. - The company has not yet generated revenue from its principal operations, with revenue recognized in 2023 related to the sale of a single unit of robotic surgical equipment[335]. Regulatory and Development Efforts - The Company submitted its 510(k) application for the surgical robot on July 19, 2024, which passed the initial FDA Administrative Review, but is currently on hold pending a complete response to an Additional Information Request[231]. - Monogram anticipates initiating a multicenter clinical trial in collaboration with Shalby Limited in 2025 to evaluate the safety and effectiveness of the Monogram TKA System[234]. - The company has not yet obtained 510(k) premarket clearances for any of its robotic products, which are necessary for commercialization[230]. - The company is focused on developing an autonomous surgical robot for orthopedic procedures, leveraging advanced technologies such as AI and machine vision[325]. - The company plans to continue its research and development efforts, with significant costs incurred in this area, including salaries and third-party contractor expenses[338]. Stock and Equity - The Company received gross proceeds of approximately $13 million from its Series D Preferred Stock Offering, which closed on October 2, 2024[241]. - The Series D Preferred Stock Offering closed on October 2, 2024, raising approximately $13 million from the sale of 5,773,979 shares and associated warrants[263]. - The company sold 292,726 shares of Common Stock to B. Riley Principal Capital II for gross proceeds of approximately $1.0 million, with the potential to sell an additional $19.0 million worth of Common Stock under the Purchase Agreement[260]. - The Company had stock options outstanding of 4,990,827 shares at December 31, 2024, with a weighted-average exercise price of $1.71 and a remaining contractual term of 7.0 years[378]. - The Company recognized no income tax expense for the years ended December 31, 2024 and 2023 due to net losses incurred[381]. Assets and Liabilities - Total current assets increased to $16,283,000 in 2024 from $14,618,000 in 2023, representing an increase of 11.4%[314]. - Total assets rose to $17,770,000 in 2024, up from $16,579,000 in 2023, reflecting a growth of 7.2%[314]. - The company reduced total liabilities to $1.7 million as of December 31, 2024, down from $2.5 million in 2023, primarily due to decreased accounts payable[273]. - The company recorded a $3.1 million increase in the fair value of the warrant liability for the year ended December 31, 2023[280]. - The company has a contingent obligation estimated at $1.5 million related to a potential "Significant Transaction" with Mount Sinai[389].
Monogram Orthopaedics (MGRM) - 2024 Q4 - Annual Results
2025-03-12 20:05
Financial Performance - Monogram Technologies reported a net loss of $16.3 million for the year ended December 31, 2024, compared to a net loss of $13.7 million in 2023, reflecting an increase of 19%[14]. - Net loss for the year ended December 31, 2024, was $14.815 million, compared to a net loss of $13.745 million for the year ended December 31, 2023[31]. - Cash used in operating activities increased to $13.968 million in 2024 from $13.543 million in 2023[31]. Expenses - Research and development expenses decreased by 17% to $8.8 million in 2024 from $10.6 million in 2023, primarily due to the completion of verification and validation phases[12]. - Marketing and advertising expenses decreased by 30% to $2.1 million in 2024 from $3.0 million in 2023, influenced by market conditions affecting fundraising efforts[13]. - General and administrative expenses increased by 9% to $4.4 million in 2024 from $4.1 million in 2023, mainly due to public company expenses[14]. - Stock-based compensation decreased to $1.174 million in 2024 from $1.559 million in 2023[31]. Cash and Financing - Cash and cash equivalents totaled $15.7 million as of December 31, 2024, up from $13.6 million as of December 31, 2023[15]. - Cash and cash equivalents at the end of the year increased to $15.658 million from $13.589 million[31]. - Proceeds from issuances of Common Stock, net, were $5.191 million in 2024, down from $15.331 million in 2023[31]. - Proceeds from issuances of Series D Preferred Stock, net, amounted to $11.130 million in 2024[31]. - Cash provided by financing activities was $16.121 million in 2024, slightly down from $16.728 million in 2023[31]. Operational Developments - Monogram completed an upsized and oversubscribed public offering raising $13 million to support strategic initiatives, including clinical trials and technology development[4]. - The company is awaiting FDA clearance for its mBôs™ Total Knee Arthroplasty System, which would enable commercialization in the U.S.[11]. - Monogram has successfully shipped a robot to India for clinical trial training and held an Investigator Meeting at a Shalby Hospital to review study protocols[9]. - Monogram plans to enhance system performance and explore domestic and international relationships as it moves toward commercialization[11]. Recognition - The company was named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook, highlighting its industry recognition[10]. Equipment and Accounts Payable - Purchases of equipment increased to $84,000 in 2024 from $65,000 in 2023[31]. - The company experienced a decrease in accounts payable, with a change of $(1.289) million in 2024 compared to an increase of $1.799 million in 2023[31].
Monogram Orthopaedics (MGRM) - 2024 Q3 - Earnings Call Transcript
2024-11-20 00:00
Financial Data and Key Metrics Changes - The company reported $16.5 million in cash at the end of Q3 2024, with a year-to-date operating cash flow of $10.9 million, indicating a cash run rate of approximately $1.2 million per month [5][6] - A significant financial raise of $13.99 million was achieved through financing activities, primarily from a successful preferred D raise that exceeded the initial target of $10 million [5][6] - The company maintains a highly variable cost structure with no traditional debt and minimal short-term warrant obligations related to the preferred D raise [6][7] Business Line Data and Key Metrics Changes - The company is focused on commercializing the first fully autonomous saw cutting robot, with all employees dedicated to this goal [9] - The submission of the first 510(k) application to the FDA was completed in July, with a subsequent additional information request received on September 30 [9][10] - The company plans to conduct an out-of-the-US clinical trial in India, collaborating with Shalby hospital chain, targeting 102 subjects for the trial [12][14] Market Data and Key Metrics Changes - The market dynamics are shifting, with 70% of fellowship programs having access to MAKO systems, and projections indicating that by 2030, one in two knee replacements will be robotic [18][19] - The company anticipates significant growth opportunities in international markets, particularly in India, where the robotic market is expanding [31][32] Company Strategy and Development Direction - The company aims to establish itself in the orthopedic robotics market by leveraging its technology to provide a more accurate and efficient surgical solution [18][19] - Plans for 2025 include launching the fully autonomous version of the robot and expanding international relationships to tap into underserved markets [16][17] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the regulatory process with the FDA and the potential for successful commercialization of their robotic system [29][30] - The company believes that the demand for robotic-assisted surgeries will continue to grow, driven by demographic trends and the aging surgeon population [18][19] Other Important Information - The company has a strong balance sheet position and expects to meet its obligations with the current cash flow and capital access [7] - The clinical trial in India is seen as a critical step for market entry, with expectations for rapid patient enrollment due to the partnership with Shalby [12][31] Q&A Session Summary Question: What is the timeline for the out-of-US India trial? - Management indicated that they have received soft approval to import the unit for training purposes and are working with a clinical research organization to finalize the application [21] Question: Will marketing costs normalize in the fourth quarter? - Management confirmed that the high marketing expenses were primarily for the campaign and are expected to decrease significantly in the upcoming quarter [22] Question: What are the anticipated revenues for 2026? - Management expects faster growth outside the US compared to domestic markets, with potential for significant revenue generation in India post-clearance [31] Question: What are the cost-saving benefits of the robotic system? - The primary cost savings stem from improved surgical outcomes and efficiency, which can lead to reduced hospital costs and increased throughput [33][34] Question: How will surgeon training be handled post-clearance? - Management believes that the training required for surgeons to use the system will be minimal, with a fast learning curve anticipated [35] Question: What is the business model for the robotic system? - The company is adopting a razor/razor blade model, where the capital equipment is offered at a lower price in exchange for commitments on consumables [36]
Monogram Orthopaedics (MGRM) - 2024 Q3 - Quarterly Report
2024-11-14 21:33
Financial Performance - The Company reported a net loss of $5,034,501 for the three months ended September 30, 2024, an 80% increase from a net loss of $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% increase compared to a net loss of $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% during the three months ended September 30, 2024, totaling $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% to $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% to $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].
Monogram Orthopaedics (MGRM) - 2024 Q3 - Quarterly Results
2024-11-14 21:07
Financial Performance - The net loss for Q3 2024 was $5.0 million, compared to a net loss of $1.0 million in the prior-year quarter, primarily due to increased marketing expenses[15]. - For the three months ended September 30, 2024, Monogram Orthopaedics reported a net loss of $5,034,501, compared to a net loss of $995,660 for the same period in 2023[25]. - The net loss per common share for the three months ended September 30, 2024, was $(0.16), compared to $(0.03) for the same period in 2023[25]. - Total operating expenses for the nine months ended September 30, 2024, were $12,390,803, a decrease from $13,391,299 in the same period of 2023, reflecting a reduction of approximately 7.4%[25]. Research and Development - Research and development expenses for Q3 2024 were $2.2 million, down from $2.7 million in the prior-year quarter, due to finalizing the validation phase of its robot prototype[13]. - Research and development expenses for the three months ended September 30, 2024, were $2,214,729, compared to $2,664,542 for the same period in 2023, indicating a decrease of about 16.8%[25]. Marketing and Advertising - Marketing and advertising expenses surged to $1.8 million in Q3 2024, compared to $32,220 in the prior-year quarter, driven by a marketing campaign for the Series D preferred stock offering[14]. Cash and Assets - Cash and cash equivalents totaled $16.6 million as of September 30, 2024, up from $13.6 million as of December 31, 2023[16]. - Total assets increased to $20.2 million as of September 30, 2024, compared to $16.6 million as of December 31, 2023[24]. - The company reported cash and cash equivalents of $16,565,142 at the end of the period, an increase from $14,875,476 at the end of September 30, 2023[26]. Stock and Shares - Proceeds from issuances of Common Stock for the three months ended September 30, 2024, amounted to $4,177,931, compared to $15,254,300 for the same period in 2023[26]. - The weighted-average number of basic and diluted shares outstanding increased to 32,223,656 for the three months ended September 30, 2024, from 29,284,949 in the same period of 2023[25]. Regulatory and Strategic Developments - The company received an Additional Information Request from the FDA regarding its 510(k) premarket filing for the mBôs TKA System, placing the application on hold pending a response[3]. - Monogram secured a strategic collaboration with Shalby Limited to conduct a multicenter clinical trial for the mBôs TKA System in India[3]. - The company anticipates an issue-specific meeting with the FDA by December 2024 to discuss the planned approach for responding to the AIR[11]. Recognition - Monogram was named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook, highlighting its industry recognition[4]. Other Financial Metrics - The company experienced a significant change in fair value of warrant liability, with a loss of $3,088,533 recorded in the nine months ended September 30, 2023[26]. - Monogram Orthopaedics reported stock-based compensation of $942,528 for the three months ended September 30, 2024, down from $1,158,499 in the same period of 2023[26]. - Cash used in operating activities for the nine months ended September 30, 2024, was $10,967,238, slightly higher than $10,430,384 for the same period in 2023[26].
Monogram Orthopaedics (MGRM) - 2024 Q2 - Quarterly Report
2024-08-15 20:32
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 $3,537,457 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 $7.0 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]. - 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 $4,832,383 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 $7,243,683 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 $1,668,043 and accrued liabilities of $677,356[78]. Cash Position and Future Outlook - As of June 30, 2024, the Company had approximately $7.3 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 $206,341 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].
Monogram Orthopaedics (MGRM) - 2024 Q2 - Earnings Call Transcript
2024-08-15 00:48
Financial Data and Key Metrics Changes - The cash position at the end of June 30, 2024, is $7.3 million, with an operating cash flow of approximately $6.4 million for the six months ended June 30, 2024 [3] - The average monthly cash burn is a little over $1 million, with efforts to maintain this level [3][4] - The company has no traditional debt or warrant obligations at this time [4] Business Line Data and Key Metrics Changes - The company successfully submitted its 510(k) application to the FDA for the mBôs TKA System on July 19, 2024, which has passed administrative review and is now in the primary substantial review phase [5][6] - A strategic clinical trial collaboration with Shalby has been established, targeting a patient population of 102 with a three-month follow-up [6][7] Market Data and Key Metrics Changes - The company anticipates leveraging clinical data from international trials for post-launch marketing in the U.S. and for launching internationally [7] - The primary addressable market in the U.S. is estimated at $20 billion, expanding to $30 billion when including extremities and spine [26] Company Strategy and Development Direction - The company aims to scale rapidly in international markets with less working capital constraints, while also preparing for a measured growth trajectory in the U.S. [7][12] - The focus is on building a robust clinical trial data set to support market entry and to validate the product's effectiveness [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA application process and the potential for a favorable outcome, emphasizing the importance of the upcoming decision [5][9] - The company is optimistic about the Indian market, citing its established infrastructure for clinical trials and the potential for significant sales growth [24][26] Other Important Information - The company plans to close its current offering in early September, with shares offered at $2.25 [15][21] - Management highlighted the competitive landscape, noting that Monogram's technology is unique compared to existing robotic systems in the market [29] Q&A Session Summary Question: Clarification on FDA submission timeframe expectations - Management clarified that the current substantial review period takes 60 days, and the FDA's average decision time is about 128 days [9] Question: Relationship with Shalby - Shalby is supporting the clinical trial and is seen as a strong partner in the Indian market, with ambitions for international growth [10][11] Question: Future cash needs and fundraising - Future cash needs will depend on the ability to execute milestones, with expectations of enhanced capital appetite as milestones are achieved [13] Question: Sales initiation post-FDA clearance - Sales ramp-up will depend on the market, with expectations for quicker market entry outside the U.S. compared to the U.S. [16] Question: Competitive landscape - Monogram's technology is positioned uniquely in the market, with a focus on active robotics, differentiating it from competitors like Mako [29]
Monogram Orthopaedics (MGRM) - 2024 Q1 - Earnings Call Transcript
2024-05-22 23:54
Financial Data and Key Metrics Changes - At the end of Q1 2024, the company's cash balance was approximately $10.1 million, with a quarterly burn rate of about $3.6 million or $1.2 million per month, which is expected to reduce to around $1 million per month in subsequent quarters [16][56][47] - Management successfully paid down accounts payable by a net of $1.1 million, related to elevated balances from Q4 activities [16] Business Line Data and Key Metrics Changes - The company has 28 full-time employees, with 60% of costs being labor, indicating a highly variable cost structure that can be significantly reduced as verification and validation (V&V) activities wind down [5] - The verification and validation testing is ongoing, with 63% of electromechanical testing complete, and the software testing is about to begin [24][45] Market Data and Key Metrics Changes - The largest competitor, Stryker, holds an 89% market share in robotic joint replacements and 75% in the cementless knee market, indicating a monopolistic market structure [8][11] - The company aims to capture market share by offering an autonomous cutting robot, which is currently not available from significant competitors [20][21] Company Strategy and Development Direction - The company plans to complete IEC 60601 certification and submit a 510(k) for FDA clearance, with expectations to complete V&V testing by the end of Q2 2024 [23][43] - The strategic vision is to advance medicine through technology adoption, focusing on becoming the first company to offer an autonomous active cutting saw-based robot [28][57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the FDA's understanding of their product and the feedback received during pre-submission communications, which is seen as constructive [18] - The company believes that achieving FDA clearance will significantly enhance its market position and facilitate entry into other markets [66] Other Important Information - The company is actively engaging with Tier 1 capital allocators and conducting site visits and demos to build relationships and support fundraising efforts [19][26] - The company has no debt and no warrant obligations, ensuring sufficient access to cash for upcoming milestones [47] Q&A Session Summary Question: Why and how does the FDA rely on an OUS clinical trial? - The FDA may rely on an OUS clinical trial to provide clinical data for marketing and to ensure safety and efficacy, with the trial being less than 100 patients and significantly cheaper than conducting it in the US [31][32] Question: What is the approval path for the active system? - The plan is to run a semi-active OUS trial first, followed by an active version trial, with a focus on building a long-term relationship with the clinical partner [33][34] Question: How does Monogram compete with Zimmer's ROSA system? - Monogram believes the opportunity lies in robotic cutting, as Mako is the only robot cutting system on the market, and Monogram aims to be the second player with an active cutting approach [64]
Monogram Orthopaedics (MGRM) - 2024 Q1 - Quarterly Results
2024-05-14 13:20
Financial Performance - The net loss for Q1 2024 was $3.5 million, an improvement compared to a net loss of $3.9 million in Q1 2023[8]. - Cash and cash equivalents decreased to $10.1 million as of March 31, 2024, down from $13.6 million as of December 31, 2023[9]. - The total assets as of March 31, 2024, were $12.5 million, down from $16.6 million as of December 31, 2023[18]. - The company reported no product revenue for Q1 2024, as it is still in the development phase[20]. Expenses - Research and development expenses for Q1 2024 were $2.4 million, up from $1.9 million in Q1 2023, reflecting the transition into the verification and validation phase of the robotic prototype[7]. - General and administrative expenses increased to $1.1 million in Q1 2024 from $0.8 million in the prior-year quarter, primarily due to higher consulting fees and regulatory compliance costs[8]. Product Development and Strategy - The company anticipates that verification and validation testing will be largely complete by the end of Q2 2024, with a 510(k) submission to the FDA expected in the second half of 2024[6]. - Monogram introduced mVision technology, which is being developed as a standalone product or for future integration into the mBôs surgical robotic system[6]. - The company is progressing towards live-patient surgery trials outside the U.S. and expanding international relationships[12]. - The mBôs surgical robot and mVision technology are gaining recognition within the orthopedic and robotics industries, supporting the commercialization strategy[4].
Monogram Orthopaedics (MGRM) - 2024 Q1 - Quarterly Report
2024-05-13 23:08
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Or Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) 3913 Todd Lane, Austin, TX 78744 (Address of principal executive offices) (Zip Code) (512) 399-2656 (Registrant's telephone number, including area code) N/A (Former name, former address and f ...