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Monogram Technologies Reports Third Quarter 2024 Financial Results Closed an Upsized and Oversubscribed $13 Million Public Offering to Fund Near-term Commercialization Milestones Management to Host Business Update Confer

Key Takeaway: Monogram Technologies Reports Third Quarter 2024 Financial Results and Oversubscribed $13 Million Public Offering to Fund Near-term Commercialization Milestones Host Business Update Conference Call on Tuesday, November 19, 2024 at 4:30 p.m. Eastern Time November 14, 2024 - Mo

Full Press Release Details

Monogram Technologies
Reports Third Quarter 2024 Financial Results
and Oversubscribed $13 Million Public Offering to Fund Near-term Commercialization Milestones
Host Business Update Conference Call on Tuesday, November 19, 2024 at 4:30 p.m. Eastern Time
November 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 third quarter ended September 30, 2024.
2024 and Subsequent Operational Highlights
Management Commentary
quarter was highlighted by an upsized and oversubscribed $13 million public offering and continued progress toward clearance for the
semi-active version of the mB s TKA System with the FDA," said Ben Sexson, Chief Executive Officer of Monogram. "Funds
from the offering are expected to provide the cash runway to meet near-term commercialization milestones and resources to support key
initiatives, including clinical trials and further development of our technology.
also working to obtain FDA clearance for our 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. According to
the 2nd Quarter FY2023 MDUFA V Performance Report, the FDA requested AIR on the first FDA review cycle for approximately 68% of
510(k) applications submitted in FY2022, and given our submission was over 28,000 pages, the AIR aligned with our
16, 2024, we held a teleconference with the agency to address clarification questions, which we found constructive. We believe this response
provides more transparency for our path forward. The FDA recommended an issue-specific submission (q submission) to discuss our planned
approach for responding to the AIR. We anticipate holding the issue-specific meeting with the FDA by December 2024. If the FDA accepts
the current planned approach, we believe we could address the AIR within the allotted period; however, this timeline could change based
on the outcome of the December issue-specific meeting wherein the FDA may comment on the planned approach.
to respond to the AIR, we have submitted an 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 mB s TKA System. Under
the collaboration, Shalby will enroll patients at various sites in India for surgeons to evaluate the safety and effectiveness of the
mB s TKA System with the Consensus CKS implant, which is substantially equivalent to the Monogram mPress implants for regulatory
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.
ahead, we are highly focused on the response to the AIR and trying to obtain FDA clearance of our 510(k) submission as quickly and economically
as possible. We are working with regulators, our Contract Research Organization (CRO) and the team at Shalby to obtain clearance
and plan logistics for our anticipated multicenter clinical trial. We are also exploring further domestic and international
relationships as we move toward commercialization. We look forward to additional updates in the weeks and months to come as we execute
on our upcoming milestones," concluded Sexson.
Third Quarter 2024 Financial Results
Research and development
expenses for the third quarter ended September 30, 2024, were $2.2 million, compared to $2.7 million in the prior-year quarter. The R&D
decrease was primarily a result of the Company finalizing the validation phase of the verification and validation phase of its robot
prototype with the submission of the application for 510 (k) FDA clearance.
Marketing and advertising
expenses for the third quarter ended September 30, 2024, were $1.8 million, compared to $32,220 in the prior-year quarter. The increase
in marketing and advertising expenses was driven by the marketing campaign to support the Series D preferred Stock Offering which commenced
in July 2024 and closed on October 2, 2024.
General & administrative
expenses for the third quarter ended September 30, 2024, were $1.1 million compared to $1.1 million in the prior-year quarter.
million for the third quarter ended September 30, 2024, as compared to a net loss of $1.0 million for the prior-year quarter. The increased
loss variance was driven primarily by the increase in marketing expenses in the third quarter ended September 30, 2024 noted above combined
with a noncash gain in the third quarter ended September 30, 2023, related to the change in fair market value of a warrant liability
that is no longer outstanding.
Cash and cash equivalents
totaled $16.6 million as of September 30, 2024, compared to $13.6 million as of December 31, 2023. The company continues to marshal its
resources with a focus on commercializing the mB s TKA System as capital efficiently as possible.
2024 Business Update Conference Call
Executive Officer Ben Sexson and Chief Financial Officer Noel Knape will host the conference call, followed by a question-and-answer
please use the following information:
Date: Tuesday, November 19, 2024
Time: 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)
Toll-free dial-in number: 1-877-407-9208
International dial-in number: 1-201-493-6784
Conference ID: 13749601
call will be broadcast live and available for replay at https://viavid.webcasts.com/starthere.jsp?ei=1693340&tp_key=7ecb89475b
and via the investor relations section of the Company's website here.
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.
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 mB s 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 mB s 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 mB s precision robot and mVision navigation.
Forward-Looking Statements
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.
Executive Vice President
Direct: 949-491-8235
MONOGRAM ORTHOPAEDICS INC.
CONDENSED BALANCE SHEETS
September 30, December 31,
2024 2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 16,565,142 $ 13,589,028
Account receivable - 364,999
Prepaid expenses and other current assets 2,065,863 664,262
Total current assets 18,631,005 14,618,289
Equipment, net of accumulated depreciation 829,216 945,020
Intangible assets, net 391,250 548,750
Operating lease right-of-use assets 370,795 466,949
Total assets $ 20,222,266 $ 16,579,008
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 1,536,663 $ 2,462,268
Accrued liabilities 874,797 227,684
Operating lease liabilities, current 135,757 128,266
Total current liabilities 2,547,217 2,818,218
Operating lease liabilities, non-current 260,904 363,724
Total liabilities 2,808,121 3,181,942
Commitments and contingencies - -
Stockholders' equity:
Series D Preferred Stock, par value $0.0001 per share; 6,000,000 shares authorized; 4,614,453 shares issued and outstanding 4,614 -
Common stock, $.001 par value; 90,000,000 shares authorized; 34,312,261 and 31,338,391 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 34,312 31,338
Additional paid-in capital 81,083,405 64,874,392
Accumulated deficit (63,708,186 ) (51,508,664 )
Total stockholders' equity 17,414,145 13,397,066
Total liabilities and stockholders' equity $ 20,222,266 $ 16,579,008
MONOGRAM ORTHOPAEDICS INC.
CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)
Three months ended Nine months ended
September 30, September 30,
2024 2023 2024 2023
Product revenue $ - $ - - -
Cost of goods sold - - $ - $ -
Gross profit - - - -
Operating expenses:
Research and development 2,214,729 2,664,542 7,047,112 7,577,907
Marketing and advertising 1,838,937 32,220 2,050,347 2,844,748
General and administrative 1,093,456 1,060,270 3,293,344 2,968,644
Total operating expenses 5,147,122 3,757,032 12,390,803 13,391,299
Loss from operations (5,147,122 ) (3,757,032 ) (12,390,803 ) (13,391,299 )
Other income:
Change in fair value of warrant liability - 2,646,399 - 3,088,533
Interest income and other, net 112,621 114,973 312,142 211,843
Total other income 112,621 2,761,372 312,142 3,300,376
Net loss before taxes (5,034,501 ) (995,660 ) (12,078,661 ) (10,090,923 )
Income taxes - - - -
Net loss $ (5,034,501 ) $ (995,660 ) $ (12,078,661 ) $ (10,090,923 )
Basic and diluted loss per common share $ (0.16 ) $ (0.03 ) $ (0.38 ) $ (0.52 )
Weighted-average number of basic and diluted shares outstanding 32,223,656 29,284,949 31,806,252 19,482,606
MONOGRAM ORTHOPAEDICS INC.
Last updated: Nov 14, 2024