Form 8-K - Current report

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of report (Date of earliest event reported): May 14, 2024

 

Monogram Orthopaedics Inc.

(Exact name of registrant as specified in its charter)

 

Delaware		001-41707		81-3777260
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

 

3919 Todd Lane, Austin, TX 78744

(Address of principal executive offices, including zip code)

 

Registrant’s telephone number, including area code: [phone]

 

Not Applicable 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		MGRM		The Nasdaq Stock Market

  

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company  x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 14, 2024, Monogram Orthopaedics Inc., a Delaware corporation (the “Company”) issued a press release announcing, among other things, its financial results for the three months ended March 31, 2024. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 7.01 Regulation FD Disclosure

 

On May 14, 2024, the Company issued a press release, providing certain operational highlights of the Company that occurred the three months ended March 31, 2024.

 

The Company plans to hold a conference call to discuss the matters set forth in the press release, followed by a question-and-answer period, on Wednesday, May 22, 2024 at 4:30 pm Eastern Time. Interested parties may participate by registering at https://streamyard.com/watch/wvMTc4vvHEgn, after which they will receive instructions on how to join participate in the meeting.

 

The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

By providing the information in Item 7.01 of this Current Report, including Exhibit 99.1 hereto, the Company is not making an admission as to the materiality of any information herein. The information contained in this Current Report is intended to be considered in the context of more complete information included in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this Current Report, except as may be required by law, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K, including the press release, contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.

 

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company’s lack of profitability and need for additional capital to grow its business; the Company’s dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of the Company’s latest annual and quarterly reports and other filings with the SEC.

 

 

 

 

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this Current Report on Form 8-K to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibit index lists the exhibits that are either filed or furnished with the Current Report on Form 8-K.

 

EXHIBIT INDEX

 

Exhibit No.	Description
99.1	Press Release dated May 14, 2024
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	MONOGRAM ORTHOPAEDICS INC.
	By:	/s/Benjamin Sexson
	Name: Benjamin Sexson
	Title: Chief Executive Officer

 

Dated: May 14, 2024

 

 

 

Exhibit 99.1

 

 

Monogram Orthopaedics Reports First Quarter 2024 Financial Results

 

Verification and Validation Testing Expected to be Largely Complete in Q2 2024; 510(k) Submission with FDA Accelerated for Second Half of 2024

  

Engaged Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S.

 

Management to Host Business Update Conference Call on Wednesday, May 22 at 4:30 p.m. Eastern Time

 

AUSTIN, TX – May 14, 2024 - Monogram Orthopaedics 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 first quarter ended March 31, 2024.

 

First Quarter 2024 and Subsequent Operational Highlights

 

·

Received feedback from the U.S. Food and Drug Administration (the “FDA”) for the Company’s verification test protocols and proposed clinical trial protocol on an outside the U.S. (OUS) target population.

·

The Company anticipates that Verification and Validation testing will be largely complete in Q2 of 2024 and anticipates a 510(k) submission to follow in the second half of 2024.

·

Introduced mVision technology, a novel approach to registration and tracking that the company is now working on as a standalone product or for integration into the mBôs surgical robotic system in the future.

·

Presented a product discussion featuring Monogram's mBôs and mVision technologies with a surgeon panel.

·

Presented at the Canaccord Genuity 2024 Musculoskeletal Conference

 

Management Commentary

 

“In the first quarter, we took the initiative to accelerate our commercial timeline by making key modifications to our strategy,” said Ben Sexson, Chief Executive Officer of Monogram. “Our team has worked tirelessly to advance Monogram toward the critical milestone of a 510(k) submission. The inherent value of our mBôs surgical robot, our mVision technology, and our underlying IP is gaining increasing recognition within both the orthopedic and robotics industries.

 

“Our communications with the FDA related to our mBôs™ TKA System verification test plan and OUS clinical trial protocol have been productive. Based on the FDA’s feedback, we believe our proposed testing plan is sufficient for evaluating the safety and effectiveness of our robotic system, supporting a strong 510(k) submission with the goal of ultimately obtaining FDA clearance. Our team has been active with the rigorous internal and external testing that encompasses the Verification and Validation phase, which we expect to be largely complete by the end of Q2 2024. We look forward to providing updates in the months to come as we continue to execute our commercialization strategy,” concluded Sexson.

  

 

 

 

Upcoming 2024 Milestones

 

·

Largely complete mBôs system verification and validation – H1 2024

·

Submit 510(k) application to FDA – H2 2024

·

Progress towards OUS live-patient surgery trials

·

Expanded international relationships

 

First Quarter 2024 Financial Results

 

Research and development expenses for the first quarter ended March 31, 2024, were $2.4 million, compared to $1.9 million the prior-year quarter. The R&D increase was primarily due to the Company moving into the verification and validation phase of its robot prototype, which is expected to be largely complete the first half of 2024, as well as the introduction of mVision technology in the first quarter.

  

General & administrative expenses for the first quarter ended March 31, 2024, were $1.1 million compared to $0.8 million in the prior-year quarter. The increase was primarily due to increases in consulting fees, insurance and regulatory compliance and professional fees.

 

Net loss was $3.5 million for the first quarter ended March 31, 2024, an improvement compared to a net loss of $3.9 million for the prior-year quarter.

 

Cash and cash equivalents totaled $10.1 million as of March 31, 2024, compared to $13.6 million as of December 31, 2023.

 

First 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, May 22, 2024
Time:	4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Registration Link:	https://streamyard.com/watch/wvMTc4vvHEgn

 

About Monogram Orthopaedics

 

Monogram Orthopaedics (NASDAQ: MGRM) is working to develop a product solution architecture with the long-term goal of enabling patient-optimized orthopedic implants at scale by linking 3D printing and robotics with advanced pre-operative imaging. The Company has a robotic system that can autonomously execute optimized paths for high-precision insertion of implants in synthetic bone specimens. Monogram 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. The Company has not yet made 510(k) premarket notification submissions or obtained 510(k) clearances for its robotic products. FDA approval is required to market these products, and the Company has not obtained FDA approval for any of its robotic products, and it cannot estimate the timing or assure the ability, to obtain such clearances.

 

 

 

 

Monogram Orthopaedics is working to advance the way orthopedic surgery is done. Our system is being developed to combine personalized knee implants with precision robotic surgical systems to give patients a better-fitting knee replacement with minimally invasive surgery. One hundred thousand knee replacements failing each year in a $19.4B market represents an enormous opportunity for us.

 

To learn more, visit www.monogramorthopedics.com.

 

Forward-Looking Statements

 

This press release may include "forward-looking statements.'' To the extent that the information presented in this presentation discusses financial projections, information, or expectations about the Company’s business plans, results of operations, products or markets, or otherwise makes statements about future events, such statements are forward-looking. Such forward-looking statements can be identified by the use of words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' Although the Company believes that the expectations reflected in these forward-looking statements 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. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading "Risk Factors" and elsewhere in the offering statement filed with the SEC. Forward-looking statements speak only as of the date of the document in which they are contained, and the Company does not undertake any duty to update any forward-looking statements except as may be required by law.

 

Investor Relations

 

Chris Tyson

Executive Vice President

MZ North America

Direct: 949-491-8235

[e-mail]

 

 

 

 

MONOGRAM ORTHOPAEDICS INC.

CONDENSED BALANCE SHEETS

 

		March 31,				December 31,
		2024				2023
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	10,077,573			$	13,589,028
Account receivable			–				364,999
Prepaid expenses and other current assets			629,751				664,262
Total current assets			10,707,324				14,618,289
Equipment, net of accumulated depreciation			903,011				945,020
Intangible assets, net			496,250				548,750
Operating lease right-of-use assets			435,116				466,949
Total assets		$	12,541,701			$	16,579,008
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	1,321,313			$	2,462,268
Accrued liabilities			531,239				227,684
Operating lease liabilities, current			131,081				128,266
Total current liabilities			1,983,633				2,818,218
Operating lease liabilities, non-current			330,561				363,724
Total liabilities			2,314,194				3,181,942
Commitments and contingencies			—				—
Stockholders' equity:
Common stock, $.001 par value; 90,000,000 shares authorized, 31,633,995 and 31,338,391 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively			31,634				31,338
Additional paid-in capital			65,211,241				64,874,392
Accumulated deficit			(55,015,368	)			(51,508,664	)
Total stockholders' equity			10,227,507				13,397,066
Total liabilities and stockholders' equity		$	12,541,701			$	16,579,008

 

 

 

 

MONOGRAM ORTHOPAEDICS INC.

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)

 

		Three months ended
		March 31,
		2024				2023
Product revenue		$	—			$	—
Cost of goods sold			—				—
Gross profit			—				—
Operating expenses:
Research and development			2,406,754				1,939,551
Marketing and advertising			119,694				1,132,625
General and administrative			1,083,711				822,889
Total operating expenses			3,610,159				3,895,065
Loss from operations			(3,610,159	)			(3,895,065	)
Other income:
Change in fair value of warrant liability			—				2,523
Interest income and other, net			103,455				34,820
Total other income			103,455				37,343
Net loss before taxes			(3,506,704	)			(3,857,722	)
Income taxes			—				—
Net loss		$	(3,506,704	)		$	(3,857,722	)
Basic and diluted loss per common share		$	(0.11	)		$	(0.40	)
Weighted-average number of basic and diluted shares outstanding			31,535,795				9,673,870

 

 

 

 

MONOGRAM ORTHOPAEDICS INC.

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

		Three months ended
		March 31,
		2024				2023
Operating activities:
Net loss		$	(3,506,704	)		$	(3,857,722	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation			294,899				368,140
Other expenses settled with stock issuances			37,500				—
Loss from change in fair value of common stock make-whole obligation			45,252				—
Depreciation and amortization			105,898				102,503
Change in fair value of warrant liability			—				(2,523	)
Changes in non-cash working capital balances:
Account receivable			364,999				—
Other current assets			(111,445	)			231,518
Accounts payable			(1,140,955	)			516,762
Accrued liabilities			258,303				(243,501	)
Operating lease assets and liabilities, net			1,485				2,446
Cash used in operating activities			(3,650,768	)			(2,882,377	)
Investing activities:
Purchases of equipment			(11,389	)			(14,792	)
Cash used in investing activities			(11,389	)			(14,792	)
Financing activities:
Proceeds from issuances of Common Stock, net of cash costs			150,702				—
Proceeds from issuances of Series C Preferred Stock, net			—				147,042
Cash provided by financing activities			150,702				147,042
Decrease in cash and cash equivalents during the period			(3,511,455	)			(2,750,127	)
Cash and cash equivalents, beginning of the period			13,589,028				10,468,645
Cash and cash equivalents, end of the period		$	10,077,573			$	7,718,518
Cash paid for interest		$	—			$	—
Cash paid for income taxes		$	—			$	—
Noncash investing and financing activities:
Amortization of deferred issuance costs of Common Stock Purchase Agreement		$	145,956			$	—
Cashless exercise of warrant		$	246			$	—

 

 

 

Cover	May 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 14, 2024
Entity File Number	001-41707
Entity Registrant Name	Monogram Orthopaedics Inc.
Entity Central Index Key	0001769759
Entity Tax Identification Number	81-3777260
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	3919 Todd Lane
Entity Address, City or Town	Austin
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	78744
City Area Code	512
Local Phone Number	399-2656
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	MGRM
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false

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