Monogram Technologies Reports Full Year 2024 Financial Results

Rhea-AI Summary

Monogram Technologies (NASDAQ:MGRM) has reported its financial results for Q4 and full year 2024. The company completed supplemental testing and submitted its response to the FDA's Additional Information Request (AIR) for its mBȏs™ TKA System. Key highlights include:

- Closed an oversubscribed $13M public offering
- Management purchased $1M of common stock in open market
- Named Orthopedic Joint Replacement Company of the Year 2024

Financial results for FY2024:
- R&D expenses: $8.8M (down 17% YoY)
- Marketing expenses: $2.1M (down 30% YoY)
- G&A expenses: $4.4M (up 9% YoY)
- Net loss: $16.3M (vs $13.7M in 2023)
- Cash position: $15.7M as of December 31, 2024

The company is advancing its collaboration with Shalby for clinical trials in India and awaiting FDA clearance decision for U.S. commercialization.

Positive

• Secured $13M through oversubscribed public offering
• Management demonstrated confidence with $1M stock purchase
• R&D expenses decreased 17% YoY to $8.8M
• Marketing expenses reduced 30% YoY to $2.1M
• Cash position improved to $15.7M from $13.6M YoY

Negative

• Net loss increased to $16.3M from $13.7M YoY
• G&A expenses increased 9% to $4.4M
• FDA clearance still pending, causing commercialization delays

Insights

Financial Analyst

Monogram's full-year 2024 results reveal a company carefully balancing pre-commercialization expenses while advancing toward key regulatory milestones. The $15.7 million cash position (up from $13.6M YoY) provides a strengthened runway following their upsized $13 million public offering. This improved liquidity comes at a critical juncture as the company prepares for potential commercialization.

The company's net loss widened to $16.3 million from $13.7 million in 2023, though this increase is largely attributable to a one-time $3 million warrant liability benefit in 2023 that didn't recur. Excluding this non-operational factor, the underlying operational performance actually shows modest improvement.

Cost discipline is evident with R&D expenses decreasing 17% to $8.8 million and marketing expenses dropping 30% to $2.1 million, reflecting the transition from development to commercialization preparation. The slight 9% increase in G&A costs to $4.4 million reflects the full-year impact of public company expenses.

The most significant near-term catalyst remains FDA clearance for their mBȏs TKA System. Having completed all supplemental testing and submitted formal responses to the FDA's Additional Information Request, Monogram now awaits a binary outcome that will determine their commercialization timeline. The $1 million insider stock purchases signal management confidence in this regulatory outcome.

The strategic partnership with Shalby advances their international strategy with shipped equipment and investigator meetings completed - creating a potential parallel commercialization path outside the US while waiting for domestic clearance.

Medical Technology Expert

Monogram's progress toward FDA clearance for their mBȏs Total Knee Arthroplasty System represents a critical inflection point. Their formal response to the FDA's Additional Information Request (AIR) following supplemental testing is encouraging, though regulatory outcomes remain inherently unpredictable.

The technology's market positioning is strengthened by industry recognition as Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook, validating their fully autonomous robotic approach in a competitive landscape dominated by surgeon-guided systems.

Their parallel strategy to conduct Outside the United States clinical trials on the fully autonomous version through Shalby creates optionality for international market entry while navigating domestic regulatory hurdles. The successful shipment of a robot and completion of an investigator meeting with Shalby Hospital demonstrates operational execution toward this goal.

The company continues to optimize system performance, focusing on workflow efficiencies and reduced cut times - critical factors for market adoption in the efficiency-driven orthopedic surgery environment. Their continued cadaveric system demos suggest maintaining clinical engagement during the regulatory waiting period.

The alliance with Reliance Life Sciences (part of one of India's largest private sector companies) to manage regulatory submissions provides credible partnership support for their international strategy. Their approach to use the Consensus CKS implant as substantially equivalent to Monogram's mPress implants for regulatory purposes demonstrates strategic thinking to potentially accelerate approvals.

While the regulatory timeline introduces uncertainty, the dual-path approach minimizes single-point regulatory failure risk while building toward their vision of advancing orthopedic surgical standards.

i

Monogram Technologies' 2024 financial results reveal a company at a critical regulatory inflection point. The firm ended 2024 with $15.7 million in cash (up from $13.6M YoY), bolstered by a successful $13 million public offering, providing runway through near-term commercialization milestones. Financial discipline is evident with R&D expenses decreasing 17% to $8.8 million and marketing costs dropping 30% to $2.1 million, though net loss widened to $16.3 million (from $13.7M in 2023), primarily due to a non-recurring $3M warrant liability benefit in 2023. The company has completed all supplemental testing and submitted its formal response to the FDA's Additional Information Request for its mBȏs TKA System, with the next anticipated communication being a clearance decision. Management expressed confidence with $1 million in open market stock purchases. Monogram is pursuing a dual-path regulatory strategy, advancing preparations for clinical trials in India with Shalby Hospitals while awaiting FDA decisions domestically. They've already shipped a robot to India and conducted investigator meetings, demonstrating operational progress toward international clinical validation. The company's technology received third-party validation as "Orthopedic Joint Replacement Company of the Year 2024" by Medical Tech Outlook, reinforcing their value proposition in the competitive orthopedic robotics landscape. While regulatory timelines introduce uncertainty, Monogram has positioned itself with improved financial stability and parallel regulatory paths to minimize single-point failure risk.

c

Initial assessment focuses heavily on financials, but may underweight regulatory significance. FDA clearance remains binary outcome with asymmetric upside/downside - success opens immediate commercialization, failure means significant delays. Dual-path regulatory strategy reduces risk but doesn't eliminate it. Need to emphasize recurring cash burn rate versus cash position (~$4M quarterly burn based on annual loss). Secondary offering strengthened balance sheet but also represents dilution. Management stock purchases positive signal but $1M relatively modest compared to total $16.3M annual loss. Should clarify decreasing R&D/marketing expenses reflect development phase completion, not concerning cuts. Pipeline beyond initial TKA system unclear - discussion of product roadmap or expansion plans. International strategy creates optionality but also complexity/costs. Industry award provides validation but minimal financial impact. Further competitor context missing - how positioned against established players? Notably absent: revenue projections, pricing strategy, specific commercial timeline post-approval. Net evaluation: maintaining neutral rating as improved financial position and regulatory progress balanced against continued losses and uncertain approval timeline. Current cash position supports roughly 4 quarters at current burn rate assuming no significant commercialization costs.

Completed all Supplemental Testing and has Submitted its Formal Response to the FDA's Additional Information Request (AIR)

Management to Host Business Update Conference Call on Wednesday, March 12, 2025, at 4:30 p.m. Eastern Time

AUSTIN, TX / ACCESS Newswire / March 12, 2025 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, has reported its financial and operational results for the fourth quarter and year ended December 31, 2024.

Fourth Quarter 2024 and Subsequent Operational Highlights

• Completed all supplemental testing and submitted its formal response to the U.S. Food and Drug Administration (FDA) regarding the Additional Information Request (AIR) received on September 30, 2024. The Company does not currently anticipate further requests for information from the FDA.

• Updates on strategic collaboration with Shalby Limited ("Shalby"), a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups include:

  • Successfully shipped a robot to support clinical trial training.

  • Held an Investigator Meeting at a Shalby Hospital in Ahmedabad, India organized by Reliance Life Sciences and attended by principal investigators, multiple surgeons, and staff to review study protocols, regulatory requirements, and operational procedures.

• Closed an upsized and oversubscribed $13 million public offering.

• Management and related parties completed open market purchases of MGRM common stock totaling $1 million.

• Named Orthopedic Joint Replacement Company of the Year 2024 by Medical Tech Outlook.

Management Commentary

"The fourth quarter was marked by continued progress toward the commercialization of our mBôs™ Total Knee Arthroplasty (TKA) System, and a strengthened balance sheet to provide the cash runway to meet near-term commercialization milestones," said Ben Sexson, Chief Executive Officer of Monogram. "Early in the quarter, we closed an upsized and oversubscribed $13 million public offering to support key strategic initiatives, including clinical trials and new technology development.

"We remain diligently focused on FDA clearance for our mBôs™ TKA System 510(k) submission. The Application was submitted on July 19, 2024, and passed the initial FDA Administrative Review. On September 30, 2024, we received an Additional Information Request ("AIR") from the FDA regarding the submission, placing the application on hold pending a complete response to the AIR within 180 days. On October 16, 2024, we held a teleconference with the FDA to address clarification questions, which we found constructive. On December 17, 2024, we conducted a positive Submission Issue Request (SIR) meeting with the FDA.

"We have now completed all supplemental testing and submitted our formal response to the FDA regarding the AIR, and do not currently anticipate further requests for information. Assuming a favorable decision by the FDA following receipt of the AIR, the next communication from them is anticipated to be a clearance decision for the mBôs™ TKA System. If granted, clearance would enable commercialization and sales of the TKA system in the United States.

"We are also moving forward with our application to run an Outside the United States ("OUS") clinical trial on the fully autonomous version of the system in collaboration with Shalby Limited, a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups. This would prepare the groundwork for the international launch of the mBȏs TKA System. Under the collaboration, Shalby will enroll patients at various sites in India for surgeons to evaluate the safety and effectiveness of the mBȏs TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory purposes.

"In January, we successfully shipped a robot to support clinical trial training to India, and an Investigator Meeting was conducted at a Shalby Hospital in Ahmedabad, India. The meeting was attended by principal investigators, multiple surgeons, and staff to review study protocols, regulatory requirements, and operational procedures. Bringing together key stakeholders, the meeting provided an opportunity for in-depth discussions on study protocols and a demonstration of the mBôs technology, reinforcing the collaborative approach to this clinical trial. The meeting was organized by Reliance Life Sciences, a Reliance Group company and one of India's largest private sector companies, which is responsible for managing the regulatory submission and communications for the clinical trial. While regulatory timelines can be variable, we remain confident in our submission and the strength of our strategic partnerships with Reliance Life Sciences and Shalby to support the process.

"During the quarter, we continued to hold cadaveric system demos, receiving surgeon and market interest for our hands-free, fully active system. With this support, we continue to believe in our thesis for orthopedic robotics and the value proposition of our proposed active robotic system and are confident such a system could be a game-changing advancement for the industry. Validating this thesis, we were recently named ‘Orthopedic Joint Replacement Company of the Year 2024' by Medical Tech Outlook from an expert panel of C-level executives, industry thought leaders, and the editorial board.

"Looking ahead, we are awaiting response from the FDA for a clearance decision for the mBôs™ TKA System, which would enable commercialization and sales in the U.S. We continue to work with regulators, our Contract Research Organization (CRO) and the team at Shalby to obtain clearance and plan logistics for our anticipated multicenter clinical trial. At the same time, we remain aggressively focused on enhancing our system's performance, including optimizing workflow efficiencies and reducing cut times, to further improve future system competitiveness. We are also exploring further domestic and international relationships as we move toward commercialization and execution of our long-term road map. Strengthened by the cash runway needed to meet all near-term commercialization milestones, we are incredibly optimistic for 2025 and our mission to advance the standard of care in orthopedic medicine." concluded Sexson.

Upcoming Milestones

• The Company is seeking to obtain FDA clearance for the mBôs™ TKA System.

• The Company is seeking to obtain regulatory clearance to conduct clinical trials in India with strategic partner Shalby Hospitals.

• Continue exploring domestic relationships.

• Continue exploring international relationships.

• Continued R&D and product development to improve future competitiveness and expand to new applications.

Full Year 2024 Financial Results

Research and development expenses for the year ended December 31, 2024, were $8.8 million, compared to $10.6 million the prior year (17%). The R&D decrease year over year was driven by the company having largely completed the verification and validation phases in the first half of 2024, resulting in overall reduction of R&D expenses in 2024 compared to 2023.

Marketing and advertising expenses for the year ended December 31, 2024, were $2.1 million, compared to $3.0 million in the prior year (30%). The decrease in marketing and advertising expenses was driven largely by market conditions that influenced the effectiveness of fundraising efforts impacting both the cost of investor acquisition and the overall success of a crowdfunded capital raise.

General & administrative expenses for the year ended December 31, 2024, increased to $4.4 million, from $4.1 million in 2023 (9%). The increase was primarily due to a full year of public company expenses primarily composed of insurance expenses, regulatory compliance expenses, and professional expenses offset by reductions in payroll and related expenses.

Net loss was $16.3 million for the year ended December 31, 2024, compared to a net loss of $13.7 million for the year ended December 31, 2023.

The net loss in 2023 was positively impacted by the change in fair value of a warrant liability of $3M that did not re-occur in 2024, as the warrant was exercised.

Cash and cash equivalents totaled $15.7 million as of December 31, 2024, compared to $13.6 million as of December 31, 2023. The company continues to direct its resources with a focus on commercializing the mBôs™ TKA System as capital efficiently as possible.

Fourth Quarter and Full Year 2024 Results Conference Call

Monogram Chief Executive Officer Ben Sexson and Chief Financial Officer Noel Knape will host the conference call, followed by a question-and-answer period.

To access the call, please use the following information:

Date:	Wednesday, March 12, 2025
Time:	4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)
Registration Link:	https://streamyard.com/watch/MHCyeqvkPqzK

The conference call webcast will be broadcast live and available for replay at the investor relations section of the Company's website here.

About Monogram Technologies Inc.

Monogram Technologies (NASDAQ: MGRM) is an AI-driven robotics company focused on improving human health, with an initial focus on orthopedic surgery. The Company is developing a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI and next-generation robotics.

Monograms mBôs precision robotic surgical system is designed to autonomously execute optimized paths for high-precision insertion of its FDA-cleared mPress press-fit implants. The goal is well balanced, better-fitting bone sparing knee replacements. The Company initially intends to produce and market robotic surgical equipment and related software, orthopedic implants, tissue ablation tools, navigation consumables, and other miscellaneous instrumentation necessary for reconstructive joint replacement procedures. Other clinical and commercial applications for the mBôs with mVision navigation are also being explored.

Monogram has obtained FDA clearance for mPress implants and applied for 510(k) clearance for its robotic products. The Company is required to obtain FDA clearance before it can market its products. Monogram cannot estimate the timing or assure the ability to obtain such clearances.

The Company believes that its mBôs precision robotic surgical assistants, which combine AI and novel navigation methods (mVision), will enable more personalized knee implants for patients, resulting in well balanced better-fitting knee replacements with bone sparing implants. Monogram anticipates that there may be other clinical and commercial applications for its navigated mBôs precision robot and mVision navigation.

To learn more, visit www.monogramtechnologies.com.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Statements other than statements of historical facts included in this press release may constitute forward-looking statements and are not guarantees of future performance or results and involve a number of risks and uncertainties. Forward-looking statements, other than statements of historical fact, are highly likely to be affected by other unknowable future events and conditions, including elements of the future that are or are not under our control, and that the Company may or may not have considered; accordingly, such statements cannot be guarantees or assurances of any aspect of future performance. Actual developments and results are highly likely to vary materially from any forward-looking statements as a result of a number of factors, including those described in the Company's filings with the SEC. The Company undertakes no duty to update any forward-looking statement made herein. All forward-looking statements speak only as of the date of this press release.

Investor Relations

Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
MGRM@mzgroup.us

MONOGRAM TECHNOLOGIES INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)

		December 31, 2024				December 31, 2023
Assets
Current assets:
Cash and cash equivalents		$	15,658			$	13,589
Account receivable			-				365
Prepaid expenses and other current assets			618				664
Total current assets			16,276				14,618
Equipment, net			810				945
Intangible assets, net			339				549
Operating lease right-of-use assets			338				467
Total assets		$	17,763			$	16,579
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	1,174			$	2,463
Accrued liabilities			209				228
Operating lease liabilities, current			138				128
Total current liabilities			1,521				2,819
Operating lease liabilities, non-current			226				364
Total liabilities			1,747				3,183
Commitments and contingencies			-				-
Stockholders' equity:
Series D Preferred Stock, $0.0001 par value; 6,000,000 shares authorized; 4,361,249 and 0 shares issued and outstanding at December 31, 2024 and 2023, respectively			4				-
Common stock, $.001 par value; 90,000,000 shares authorized; 35,167,673and 31,338,391 shares issued and outstanding at December 31, 2024 and 2023, respectively			35				31
Additional paid-in capital			82,452				64,874
Accumulated deficit			(66,475	)			(51,509	)
Total stockholders' equity			16,016				13,396
Total liabilities and stockholders' equity		$	17,763			$	16,579

MONOGRAM TECHNOLOGIES INC.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)

		Years Ended
		December 31, 2024				December 31, 2023
Revenue		$	-			$	365
Operating expenses:
Research and development			8,777				10,586
Marketing and advertising			2,108				2,994
General and administrative			4,412				4,053
Total operating expenses			15,297				17,633
Loss from operations			(15,297	)			(17,268	)
Other income:
Change in fair value of warrant liability			-				3,089
Interest income and other, net			482				434
Total other income, net			482				3,523
Net loss before taxes			(14,815	)			(13,745	)
Income taxes			-				-
Net loss			(14,815	)			(13,745	)
Less: dividends declared for preferred shareholders			(151	)			-
Net loss allocable to common shareholders		$	(14,966	)		$	(13,745	)
Basic and diluted loss per common share		$	(0.46	)		$	(0.61	)
Weighted-average number of basic and diluted shares outstanding			32,571,470				22,409,222

MONOGRAM TECHNOLOGIES INC.
STATEMENTS OF CASH FLOWS
(in thousands)

		Years Ended
		December 31, 2024				December 31, 2023
Operating activities:
Net loss		$	(14,815	)		$	(13,745	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation			1,174				1,559
Other expenses settled with stock issuances			50				130
Loss from change in fair value of common stock make-whole obligation			45				44
Depreciation and amortization			430				412
Change in fair value of warrant liability			-				(3,089	)
Changes in non-cash working capital balances:
Account receivable			365				(365	)
Prepaid expenses and other current assets			46				270
Accounts payable			(1,289	)			1,799
Accrued liabilities			26				(565	)
Operating lease assets and liabilities, net			-				7
Cash used in operating activities			(13,968	)			(13,543	)
Investing activities:
Purchases of equipment			(84	)			(65	)
Cash used in investing activities			(84	)			(65	)
Financing activities:
Proceeds from issuances of Common Stock, net			5,191				15,331
Repurchases of Common Stock			(200	)			-
Proceeds from issuances of Series C Preferred Stock, net			-				147
Proceeds from issuances of Series D Preferred Stock, net			11,130
Proceeds from warrant exercise			-				1,250
Cash provided by financing activities			16,121				16,728
Increase in cash and cash equivalents during the year			2,069				3,120
Cash and cash equivalents, beginning of the year			13,589				10,469
Cash and cash equivalents, end of the year		$	15,658			$	13,589
Non-cash investing and financing activities:
Series D Preferred Stock dividends settled through issuance of Common Stock		$	151			$	-
Issuance costs related to Common Stock Purchase Agreement settled through issuance of Common Stock		$	-			$	248
Cashless exercise of warrant		$	-			$	926

SOURCE: Monogram Technologies Inc.

View the original press release on ACCESS Newswire

FAQ

What is the current status of MGRM's FDA clearance for the mBȏs™ TKA System?

MGRM has completed supplemental testing and submitted its formal response to the FDA's Additional Information Request (AIR) received on September 30, 2024. The company awaits FDA's clearance decision.

How much did MGRM's R&D expenses decrease in 2024?

R&D expenses decreased by 17% to $8.8M in 2024 from $10.6M in 2023, due to completion of verification and validation phases in early 2024.

What is the progress of MGRM's partnership with Shalby in India?

MGRM has shipped a robot for clinical trial training and held an Investigator Meeting at Shalby Hospital in Ahmedabad, preparing for OUS clinical trials of their autonomous system.

What is MGRM's current cash position as of December 31, 2024?

MGRM reported cash and cash equivalents of $15.7M as of December 31, 2024, compared to $13.6M at the end of 2023.