Monogram Technologies Reports Second Quarter 2024 Financial Results

Rhea-AI Summary

Monogram Technologies (NASDAQ:MGRM) reported its Q2 2024 financial results, highlighting key operational achievements. The company submitted a 510(k) premarket filing to the FDA for its mBôs TKA System, which passed the administrative review. Monogram also secured a strategic collaboration with Shalby for multicenter clinical trials in India. Financial results showed R&D expenses decreased to $2.4 million from $3.0 million year-over-year, while marketing expenses significantly dropped to $92,000 from $1.7 million. The net loss improved to $3.5 million compared to $5.2 million in the prior-year quarter. Cash and cash equivalents stood at $7.3 million as of June 30, 2024.

Positive

• Submitted 510(k) premarket filing to FDA for mBôs TKA System and passed administrative review
• Secured strategic collaboration with Shalby for multicenter clinical trials in India
• R&D expenses decreased from $3.0 million to $2.4 million year-over-year
• Net loss improved from $5.2 million to $3.5 million year-over-year
• Marketing expenses significantly reduced from $1.7 million to $92,000

Negative

• Cash and cash equivalents decreased from $13.6 million (Dec 31, 2023) to $7.3 million (Jun 30, 2024)

Financial Analyst

Monogram Technologies' Q2 2024 results show a mixed financial picture. While R&D expenses decreased from $3.0M to $2.4M year-over-year, this reduction is primarily due to the company moving into the validation phase of product development. The significant drop in marketing expenses from $1.7M to $92,000 is noteworthy but tied to the completion of a specific offering campaign.

The net loss improved from $5.2M to $3.5M, mainly due to reduced expenses. However, cash and equivalents decreased from $13.6M to $7.3M over six months, indicating a burn rate that investors should monitor closely. The lack of revenue highlights that Monogram is still in a pre-commercial phase, making the FDA decision on their 510(k) application crucial for future prospects.

Medical Research Analyst

The submission of the 510(k) premarket filing for the mBôs TKA System is a significant milestone. The 28,000-page application, including validation from 15 surgeons in simulated cadaveric surgeries, demonstrates thorough preparation. However, investors should note that while a decision is expected within 90 days, delays are possible if additional information is requested.

The collaboration with Shalby for clinical trials in India is strategically important. Shalby's position as the world's largest orthopedic hospital chain by arthroplasty volume provides an excellent platform for evaluating the system's safety and effectiveness. This partnership could accelerate international market entry and provide valuable real-world data, potentially strengthening Monogram's position in the competitive orthopedic robotics market.

Market Research Analyst

Monogram's strategic shift towards AI-driven robotics, reflected in its name change, aligns with growing market trends in medical technology. The focus on patient-optimized orthopedic implants using 3D printing, advanced machine vision and AI positions the company at the forefront of personalized medicine.

The launch of a continuous offering of 8.00% convertible preferred stock and warrants suggests a proactive approach to funding future growth. However, investors should consider the potential dilutive effects. The company's ability to secure FDA clearance and successfully conduct clinical trials will be critical factors in determining its market position and potential for revenue generation in the highly competitive orthopedic surgery market.

Submitted FDA 510(k) Application and Passed FDA Administrative Review for the mBôs TKA System

Secured Initial Strategic Multicenter Clinical Trial Collaboration with Shalby Limited

Management to Host Business Update Conference Call Today at 4:30 p.m. Eastern Time

AUSTIN, TX / ACCESSWIRE / August 14, 2024 / 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 second quarter ended June 30, 2024.

Second Quarter 2024 and Subsequent Operational Highlights

• Submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for the Company's mBôs TKA System and passed the FDA Administrative Review.

• Secured initial strategic collaboration with Shalby Limited ("Shalby"), a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups, to conduct a multicenter clinical trial to demonstrate the safety and effectiveness of the mBȏs TKA System.

• Completed corporate name change to Monogram Technologies reflecting its continued evolution as an AI-driven robotics company with a strong IP position.

• Hosted an Investor and Analyst Tour at its headquarters in Austin, Texas, showcasing a product demonstration of mBôs Precision Robotic Surgical System and mVision Technologies

• Launched a continuous offering of 8.00% convertible preferred stock and warrants.

Management Commentary

"In the second quarter we made significant progress on key milestones with a 510(k) premarket filing to the FDA for our mBôs TKA System, and a new partnership to begin clinical trials in India," said Ben Sexson, Chief Executive Officer of Monogram. "The application passed the FDA Administrative Review, and a decision is expected within 90 days of the initial submission, although the process may take longer if additional information is requested. We believe this is a very strong application at over 28,000-pages, and the culmination of over eight years and thousands of hours, comprising verification and validation from numerous, extremely rigorous tests including simulated cadaveric surgeries by fifteen surgeons.

"Our clinical trial collaboration with Shalby Limited, a global multi-specialty hospital chain and one of India's leading orthopedic hospital groups follows this 510(k) submission, setting the stage for the international launch of the mBȏs TKA System. Shalby is the largest (ranked #1 in arthroplasty by volume) orthopedic hospital chain in the world employing over 4,000 people at 14 hospitals in 13 cities and more than 3 million patients treated. 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.

"Operationally during the second quarter, we took the opportunity to update our corporate name to better reflect our continued evolution as an AI-driven robotics company and the broadening applications for our technology long term. We were also excited to offer our loyal followers and shareholders the opportunity to participate in a Unit offering typically reserved for institutional investors. Finally, a successful Investor and Analyst Day at our headquarters demonstrated our work to develop a product solution architecture to enable patient-optimized orthopedic implants at scale by combining 3D printing, advanced machine vision, AI, and next-generation robotics.

"Looking ahead, we are focused on the successful FDA clearance of our 510(k) submission in the expected 90-day timeframe. Based on the FDA's previous feedback, we believe our proposed testing plan is sufficient for evaluating the safety and effectiveness of our robotic system, supporting this strong 510(k) submission. We are now working with the team at Shalby to begin enrollment of patients in our multicenter clinical trial. Taken together, we continue to execute on our milestones toward commercialization and look forward to additional updates as we work to provide long-term value for our shareholders," concluded Sexson.

Upcoming 2024 Milestones

• Obtain clearance for the mBôs™ TKA System following FDA decision

• Progress towards OUS live-patient surgery trials

• Expanded international relationships

Second Quarter 2024 Financial Results

Research and development expenses for the second quarter ended June 30, 2024, were $2.4 million, compared to $3.0 million in the prior-year quarter. The R&D decrease was primarily a result of the Company moving more into the validation phase of the verification and validation phase, which the Company largely completed in the first half of 2024. The move into the validation phase, which consisted largely of testing and documenting the system components and protocols led to significant decreases in prototype material and contractor services spend which were primarily incurred in connection with the verification phase.

Marketing and advertising expenses decreased from $1.7 million to $92,000 for the second quarter ended June 30, 2024 compared to the prior year quarter. Marketing and advertising expenses incurred during the three months ended June 30, 2023 were primarily related Company's marketing campaign for its Regulation A - Tier 2 offering of its Common Stock (the "Reg A Common Stock Offering") that began during the three months ended March 31, 2023 and successfully culminated with a round closing in May of 2023. The marketing expenses in 2024 related primarily to advertising to drive awareness of the company's NASDAQ listing and increase the volume of trading activity.

General & administrative expenses for the second quarter ended June 30, 2024, were $1.1 million compared to $1.1 million in the prior-year quarter.

Net loss of $3.5 million for the second quarter ended June 30, 2024, was an improvement compared to a net loss of $5.2 million for the prior-year quarter, driven primarily by the decrease in marketing and advertising spend and the reduction in R&D spend noted above.

Cash and cash equivalents totaled $7.3 million as of June 30, 2024, compared to $13.6 million as of December 31, 2023. The company continues to marshall its resources with a focus on commercializing the mBôs™ TKA System as capital efficiently as possible.

Second Quarter 2024 Business Update 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, August 14, 2024
Time:	4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Registration Link:	https://streamyard.com/watch/b2wwqt5vfh9E

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. For example, the Company's statement regarding the Company's proposed use of net proceeds is a forward-looking statement. 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 prospectus and the Company's other 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.
CONDENSED BALANCE SHEETS

		June 30,				December 31,
		2024				2023
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	7,306,069			$	13,589,028
Account receivable			-				364,999
Prepaid expenses and other current assets			814,999				664,262
Total current assets			8,121,068				14,618,289
Equipment, net of accumulated depreciation			848,664				945,020
Intangible assets, net			443,750				548,750
Operating lease right-of-use assets			403,068				466,949
Total assets		$	9,816,550			$	16,579,008
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	1,668,043			$	2,462,268
Accrued liabilities			677,356				227,684
Operating lease liabilities, current			133,406				128,266
Total current liabilities			2,478,805				2,818,218
Operating lease liabilities, non-current			295,963				363,724
Total liabilities			2,774,768				3,181,942
Commitments and contingencies			-				-
Stockholders' equity:
Common stock, $.001 par value; 90,000,000 shares authorized, 31,670,375 and 31,338,391 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			31,669				31,338
Additional paid-in capital			65,562,938				64,874,392
Accumulated deficit			(58,552,825	)			(51,508,664	)
Total stockholders' equity			7,041,782				13,397,066
Total liabilities and stockholders' equity		$	9,816,550			$	16,579,008

MONOGRAM TECHNOLOGIES INC.
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)

		Three months ended								Six months ended
		June 30,								June 30,
		2024				2023				2024				2023
Product revenue		$	-			$	-				-				-
Cost of goods sold			-				-			$	-			$	-
Gross profit			-				-				-
Operating expenses:
Research and development			2,425,629				2,973,815				4,832,383				4,913,366
Marketing and advertising			91,715				1,679,902				211,410				2,812,527
General and administrative			1,116,179				1,084,485				2,199,890				1,908,404
Total operating expenses			3,633,523				5,738,202				7,243,683				9,634,267
Loss from operations			(3,633,523	)			(5,738,202	)			(7,243,683	)			(9,634,267	)
Other income:
Change in fair value of warrant liability			-				439,611				-				442,134
Interest income and other, net			96,066				61,710				199,522				96,530
Other income (expense)			-				339				-				340
Total other income			96,066				501,660				199,522				539,004
Net loss before taxes			(3,537,457	)			(5,236,541	)			(7,044,161	)			(9,095,263	)
Income taxes			-				-				-				-
Net loss		$	(3,537,457	)		$	(5,236,541	)		$	(7,044,161	)		$	(9,095,263	)
Basic and diluted loss per common share		$	(0.11	)		$	(0.27	)		$	(0.22	)		$	(0.63	)
Weighted-average number of basic and diluted shares outstanding			31,559,892				19,271,521				31,597,148				14,472,695

MONOGRAM TECHNOLOGIES INC.
CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)

		Six months ended
		June 30,
		2024				2023
Operating activities:
Net loss		$	(7,044,161	)		$	(9,095,263	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation			578,493				783,260
Other expenses settled with stock issuances			50,000				-
Loss from change in fair value of common stock make-whole obligation			58,375				-
Depreciation and amortization			212,744				204,186
Change in fair value of warrant liability			-				(442,134	)
Changes in non-cash working capital balances:
Account receivable			364,999				-
Other current assets			(296,693	)			(621,080	)
Accounts payable			(794,225	)			792,062
Accrued liabilities			391,297				(393,632	)
Operating lease assets and liabilities, net			1,260				4,137
Cash used in operating activities			(6,477,911	)			(8,768,464	)
Investing activities:
Purchases of equipment			(11,389	)			(37,409	)
Cash used in investing activities			(11,389	)			(37,409	)
Financing activities:
Proceeds from issuances of Common Stock, net of cash costs			206,341				15,287,860
Proceeds from issuances of Series C Preferred Stock, net			-				147,042
Cash provided by financing activities			206,341				15,434,902
Increase (decrease) in cash and cash equivalents during the period			(6,282,959	)			6,629,030
Cash and cash equivalents, beginning of the period			13,589,028				10,468,645
Cash and cash equivalents, end of the period		$	7,306,069			$	17,097,675
Noncash investing and financing activities:
Amortization of deferred issuance costs of Common Stock Purchase Agreement		$	145,956			$	-
Cashless exercise of warrant		$	246			$	926,335

SOURCE: Monogram Technologies Inc.

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FAQ

What were Monogram Technologies' (MGRM) key financial results for Q2 2024?

Monogram Technologies reported a net loss of $3.5 million, R&D expenses of $2.4 million, and marketing expenses of $92,000 for Q2 2024. Cash and cash equivalents totaled $7.3 million as of June 30, 2024.

What significant operational milestones did Monogram Technologies (MGRM) achieve in Q2 2024?

Monogram Technologies submitted a 510(k) premarket filing to the FDA for its mBôs TKA System, which passed the administrative review. The company also secured a strategic collaboration with Shalby for multicenter clinical trials in India.

How did Monogram Technologies' (MGRM) R&D expenses change in Q2 2024 compared to the previous year?

Monogram Technologies' R&D expenses decreased from $3.0 million in Q2 2023 to $2.4 million in Q2 2024, primarily due to the company moving into the validation phase of product development.

What is the expected timeline for FDA clearance of Monogram Technologies' (MGRM) mBôs TKA System?

Monogram Technologies expects a decision on their 510(k) submission for the mBôs TKA System within 90 days of the initial submission, although the process may take longer if additional information is requested.