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 / ACCESSWIRE / 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
MGRM@mzgroup.us
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 | $ | - | ||||
SOURCE: MONOGRAM ORTHOPAEDICS INC
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