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].

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 Technologies Inc. (NASDAQ:MGRM) Q1 2024 Earnings Conference Call May 22, 2024 4:30 PM ET Company Participants Larry Holub - Investor Relations, MZ Group North America Noel Knape - Chief Financial Officer Ben Sexson - Chief Executive Officer Larry Holub Welcome to the Monogram Technologies First Quarter 2024 Business Update Conference Call. I'm Larry Holub, Director at MZ Group North America, representing Monogram Technologies as their external Investor Relations Adviser. At this time, all participa ...

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].

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 ...

Monogram Orthopaedics, Inc. (NASDAQ:MGRM) Q4 2023 Earnings Conference Call March 21, 2024 5:00 PM ET Company Participants Benjamin Sexson - CEO Noel Knape - CFO Doug Unis - Founder and CMO Kamran Shamaei - CTO Conference Call Participants Benjamin Sexson Okay, great. Thanks Greg. Well, good afternoon, everybody. We really appreciate you joining us today for this Update Call. I want to try and lay a couple of ground rules from the start. We're going to be really collaborative on this. You're going to be able ...

ity monogram FY 2023 Investor Call NASDAQ: M G R M 2 Although Monogram believes that the expectations reflected in this presentation are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. 3 • Detailed Regulatory Strategy Review • mBôs Features December 31, 2023 Select Information: • Highly variable cost structure • Expect sufficient access to cash through 510k approval • mBôs is a Class II ...

Exhibit 99.1 Monogram Orthopaedics Reports Full Year 2023 Financial Results 510(k) Submission with FDA On Track for Second Half of 2024 Shipped mBôs Surgical Robot System to First International Customer Introduced mVision Technologies, a Novel Approach to Registration and Tracking Management to Host Business Update Conference Call on Thursday, March 21 at 5:00 p.m. Eastern Time AUSTIN, TX – March 15, 2024 - Monogram Orthopaedics Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), a medical technology company ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 ☐ Transition Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission file number 001-41707 Monogram Orthopaedics Inc. (Exact name of registrant as specified in its charter) Delaware 81-2349540 (State or Other Juris ...

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 September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _____________ Commission file number: 001-41707 3913 Todd Lane, Austin, TX 78744 (Address of principal executive offices) (Zip Co ...