Conference Call/Webcast Today at
5 pm ET
TORONTO and DALLAS, Nov. 14,
2024 /CNW/ - Perimeter Medical Imaging AI, Inc.
(TSXV: PINK) (OTC: PYNKF) ("Perimeter" or the "Company"),
a commercial-stage medical technology company, today reported
financial results for its third quarter ended September 30, 2024 and provided a corporate
update.
Business Highlights
- The Company continues to gain positive commercial market
traction with its first U.S. Food and Drug Administration
("FDA")-cleared product, Perimeter S-Series OCT. It has already
achieved eight (8) new S-Series OCT system placements year-to-date,
compared to a total of three (3) for all of 2023, and Q3-2024
revenues grew 142% over Q3-2023. In addition, the Company is
advancing the development of its next-generation Perimeter B-Series
OCT system, which combines proprietary AI technology with OCT,
toward potential commercialization.
- In the 2024 third quarter, Perimeter also recognized revenue
for the first time from its sale of service contracts. The Company
has entered into three (3)-year Equipment Service Plan ("ESP")
warranty programs with several S-Series OCT customers, which
provide for annual preventative maintenance of the OCT equipment.
The total value of ESP warranty programs will be recognized over
their terms as services are rendered.
- In September 2024, Perimeter
announced the first closing of its non-brokered private placement
(the "Offering") where the Company issued 23,470,560 common shares
for gross proceeds of approximately $9,857,635 Canadian dollars. Subsequent to the
end of the third quarter, Perimeter announced the second and final
closing of the Offering where the company issued 4,846,501 common
shares at a price of $0.42 per common
share, for gross proceeds of $2,035,530. In total, the Company has issued
28,317,061 common shares for aggregate gross proceeds of
$11,893,166 under the Offering.
- In October 2024, Perimeter
announced the completion of patient enrollment in the ongoing
pivotal clinical trial evaluating the use of its next-generation
B-Series OCT system, which combines proprietary artificial
intelligence ("AI") technology with optical coherence tomography
("OCT"), during breast-conserving surgeries. If successful, the
trial is expected to support the Company's submission to the FDA
for authorization to market the Perimeter B-Series OCT in
the United States.
"We are very much looking forward to sharing the primary
endpoint results of the pivotal clinical trial evaluating our
proprietary B-Series OCT with ImgAssist AI in breast-conserving
surgeries," commented Adrian Mendes,
Perimeter's Chief Executive Officer. "We anticipate announcing the
top-line results shortly. Accordingly, this evening's investor
conference call comes at an opportune time as we frame the
importance of this key potential inflection point for the growth of
our business."
Third Quarter 2024 Financial Results
Unless specified otherwise, all amounts in this press release
are expressed in U.S. dollars and are presented in accordance with
International Financial Reporting Standards as issued by the
International Accounting Standards Board.
The Company reported third quarter 2024 revenues of
approximately $208,000, which
consisted of the sale of consumables and system leases, as well as
from the sale of ESP warranty programs. Third quarter 2024 revenues
increased 142% over Q3-2023. Revenue growth was driven by continued
commercial adoption of Perimeter S-Series OCT, both in terms of
existing system utilization and installed base growth.
Operating expenses for the three months ended September 30, 2024 were approximately
$4.5 million, essentially unchanged
from the same period in 2023.
Third quarter 2024 net loss was approximately $4.6 million, or $0.07 per common share, compared to a net loss of
approximately $345,000, or
$0.01 per common share, in the three
months ended September 30, 2023. The
increase in net loss was primarily the result of a change in two
non-cash expenses: net finance expense resulting from the
revaluation of the warrant liability and net foreign exchange
loss.
Cash used in operating activities in the nine months ended
September 30, 2024, was approximately
$11.6 million, compared to
approximately $10.6 million in the
comparable period in 2023.
As of September 30, 2024, cash and
cash equivalents were approximately $9.5
million. This amount does not include any of the of the
approximately $1.5 million
(C$2.0 million) in gross proceeds
from the second and final closing of the Offering, nor a Cancer
Prevention and Research Institute of Texas (CPRIT) grant receivable of
approximately $1.9 million, which is
related to the reimbursement of pivotal clinical trial project
costs, as of the end of the 2024 third quarter.
For detailed financial results, please refer to Perimeter's
filings on SEDAR+ and the Company's website.
Conference Call
The Company will host a conference call and live audio webcast
today at 5:00 pm Eastern Time to
discuss its second quarter 2024 results and provide a corporate
update. To participate in the call, please dial 1-800-717-1738 or
1-646-307-1865. The conference call will also be broadcast live
online through a listen-only webcast, which will be posted on the
Investors section of the Company's website and archived for
approximately 90 days.
About Perimeter Medical Imaging AI, Inc.
Based in Toronto, Canada and
Dallas, Texas, Perimeter Medical
Imaging AI (TSX-V: PINK) (OTC: PYNKF) is a medical technology
company driven to transform cancer surgery with
ultra-high-resolution, real-time, advanced imaging tools to address
areas of high unmet medical need. Available across the U.S., our
FDA-cleared Perimeter S-Series OCT system provides real-time,
cross-sectional visualization of excised tissues at the cellular
level. The breakthrough-device-designated investigational Perimeter
B-Series OCT with ImgAssist AI represents our next-generation
artificial intelligence technology that is currently being
evaluated in a pivotal clinical trial, with support from a grant of
up to US$7.4 million awarded by the
Cancer Prevention and Research Institute of Texas. The company's ticker symbol "PINK" is a
reference to the pink ribbons used during Breast Cancer Awareness
Month.
Perimeter B-Series OCT is limited by U.S. law to
investigational use and not available for sale in the United States. Perimeter S-Series OCT has
510(k) clearance under a general indication and has not been
evaluated by the U.S. FDA specifically for use in breast tissue,
breast cancer, other types of cancer, margin evaluation, and
reducing re-excision rates. The safety and effectiveness of these
uses has not been established. For more information, please visit
www.perimetermed.com/disclosures.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
Forward-Looking Statements
This news release contains statements that constitute
"forward-looking information" within the meaning of applicable
Canadian securities legislation. In this news release, words such
as "may," "would," "could," "will," "likely," "believe," "expect,"
"anticipate," "intend," "plan," "estimate," and similar words and
the negative form thereof are used to identify forward-looking
statements. Forward-looking information may relate to management's
future outlook and anticipated events or results and may include
statements or information regarding the future financial position,
business strategy and strategic goals, competitive conditions,
research and development activities, projected costs and capital
expenditures, research and clinical testing outcomes, taxes and
plans and objectives of, or involving, Perimeter. Without
limitation, information regarding the potential benefits of
Perimeter S-Series OCT and Perimeter B-Series OCT, the expected
benefits of Perimeter's updated version of its ImgAssist AI, and
Perimeter's expectations regarding the outcomes of the clinical
trial are forward-looking information. Forward-looking statements
should not be read as guarantees of future performance or results,
and will not necessarily be accurate indications of whether, or the
times at or by which, any particular result will be achieved. No
assurance can be given that any events anticipated by the
forward-looking information will transpire or occur.
Forward-looking information is based on information available at
the time and/or management's good-faith belief with respect to
future events and are subject to known or unknown risks,
uncertainties, assumptions, and other unpredictable factors, many
of which are beyond Perimeter's control. Such forward-looking
statements reflect Perimeter's current view with respect to future
events, but are inherently subject to significant medical,
scientific, business, economic, competitive, political, and social
uncertainties and contingencies. In making forward-looking
statements, Perimeter may make various material assumptions,
including but not limited to (i) the accuracy of Perimeter's
financial projections; (ii) obtaining positive results from trials;
(iii) obtaining necessary regulatory approvals; and (iv) general
business, market, and economic conditions. Further risks,
uncertainties and assumptions include, but are not limited to,
those applicable to Perimeter and described in Perimeter's
Management Discussion and Analysis for the year ended December 31, 2023, which is available on
Perimeter's SEDAR+ profile at https://www.sedarplus.ca, and could
cause actual events or results to differ materially from those
projected in any forward-looking statements. Perimeter does not
intend, nor does Perimeter undertake any obligation, to update or
revise any forward-looking information contained in this news
release to reflect subsequent information, events, or circumstances
or otherwise, except if required by applicable laws.
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SOURCE Perimeter Medical Imaging AI Inc.
