12:26:07 EDT Tue 21 May 2024
Enter Symbol
or Name
USA
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Perimeter Medical Imaging AI Inc
Symbol PINK
Shares Issued 64,675,739
Close 2023-08-29 C$ 1.45
Market Cap C$ 93,779,822
Recent Sedar Documents

Perimeter loses $4.9-million (U.S.) in Q2

2023-08-29 16:13 ET - News Release

Mr. Adrian Mendes reports

PERIMETER MEDICAL IMAGING AI REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Perimeter Medical Imaging AI Inc. has released financial results for its second quarter ended June 30, 2023, and has provided a corporate update. All of the amounts are expressed in U.S. dollars unless otherwise indicated and are presented in accordance with international financial reporting standards as issued by the International Accounting Standards Board.

Key highlights:

  • Completed a leadership transition with appointment of new chief executive officer and board member, and expanded its leadership team with appointment of chief financial officer and chief innovation officer;
  • Received regulatory approval to implement a substantially enhanced artificial intelligence algorithm in the continuing pivotal clinical trial under the existing study protocol;
  • Initiated additional clinical trial sites at Baptist MD Anderson Cancer Center and Mayo Clinic in Florida;
  • Expanded its customer base with commercial installations of Perimeter's flagship S-Series OCT in the states of Utah and Georgia.

Adrian Mendes, Perimeter's chief executive officer, stated: "I am pleased to report a number of significant developments within the business since joining Perimeter as its CEO this quarter. Concurrent with my appointment, Dr. Josh Vose joined our board of directors and has provided invaluable insights into our clinical development program. Importantly, we received approval from the [Food and Drug Administration] to introduce an enhanced AI algorithm in the ongoing clinical trial under the existing study protocol. As a result, all clinical trial sites, including the newest trial site at Mayo Clinic in Florida, will use the updated AI as patients continue to enroll in the study. We are currently engaged in ongoing discussions with the FDA to reach alignment on subject enrolment and secondary reporting within the clinical trial, and we intend to provide an update on guidance and next steps when this regulatory feedback is received."

Mr. Mendes continued: "I believe the introduction of this improved AI is a pivotal milestone for the company and the best path forward as it will contribute to more accurate image classifications, as well as fewer false positives and negatives, with the goal of ultimately compiling a robust data package that supports the commercialization of Perimeter B-Series OCT with ImgAssist AI. The combination of advanced AI technology with OCT truly represents the next generation of innovations coming out of Perimeter that could potentially change the standard of care in breast conservation surgery, and it was a key element that attracted me -- as well as world-class leaders such as Anantha Kancherla, former head of AI platform at Meta -- to the company."

Mr. Mendes added: "We continue to grow our roster of highly respected surgeons and key opinion leaders, who are championing our flagship Perimeter S-Series OCT and establishing the foundational reference sites for Perimeter's transformational technologies. Of note, we continue to generate new sales leads and commercial demos, with recent expansion into the states of Utah and Georgia. In addition, I am pleased to report that Sara Brien will become Perimeter's chief financial officer, effective Sept. 1, 2023. We are grateful for Russell Wagner's service as our interim CFO, and he and Sara will work together to ensure a smooth transition on this front. I am also pleased to confirm Andrew Berkeley, one of Perimeter's co-founders, will transition his role to chief innovation officer, which reflects Andrew's deep technical and clinical knowledge and our commitment to continue to develop game-changing technologies by applying engineering advancements and innovation across all areas of the business."

Business updates:

  • Perimeter completed the first commercial placement of its flagship Perimeter S-Series OCT system in the state of Utah and, subsequent to quarter-end, completed its first commercial placement in the state of Georgia.
  • Perimeter provided an update on its continuing multicentre, randomized, two-arm pivotal clinical trial led by principal investigator, Dr. Alastair Thompson, at the Baylor College of Medicine in Houston. The study is evaluating the use of Perimeter B-Series OCT combined with its proprietary ImgAssist AI software during breast conservation surgery:
    • Perimeter received approval from the FDA to introduce an enhanced AI algorithm in the continuing clinical trial under the existing study protocol. As a result, all clinical trial sites will use the updated AI as patients continue to enroll in the continuing study.
    • The new enhanced AI takes advantage of additional training data and Perimeter's latest AI advancements that demonstrate improved sensitivity, specificity, precision and recall. It is expected that this updated version of ImgAssist AI will contribute to more accurate classification, as well as fewer false positives and negatives.
    • To further support patient enrolment, Perimeter initiated an additional clinical trial site at Baptist MD Anderson Cancer Center in Jacksonville, Fla., and, subsequent to quarter-end, initiated another clinical trial site at Mayo Clinic in Florida.
    • Perimeter is currently engaged in continuing discussions with the FDA to reach alignment on subject enrolment and secondary reporting, which are expected over the next couple of weeks. Updated guidance on study completion will be provided following receipt of FDA feedback.
  • Perimeter expanded its leadership team by adding Dr. Vose to Perimeter's board of directors. The recent leadership transition also included the appointment of Mr. Mendes as chief executive officer and the transition of Mr. Berkeley (company co-founder) to chief innovation officer, in support of the company's strategic focus on product innovation. In addition, Ms. Brien will be appointed chief financial officer (effective Sept. 1, 2023) subject to customary regulatory approvals:
    • Ms. Brien is an accomplished finance leader with over 20 years of experience across a variety of health care verticals, including pharmaceuticals, diagnostics, medtech and healthtech. She holds a certified management accountant (CMA) designation, and graduated with honours from the University of Waterloo in Ontario, Canada, with a bachelor of science in kinesiology and a master of management science with a focus on operations. Recently, she was a Sloan fellow at the London Business School, where she completed a master in leadership and strategy program.

Summary of second quarter 2023 financial results

All of the amounts are expressed in U.S. dollars unless otherwise indicated and are presented in accordance with international financial reporting standards as issued by the International Accounting Standards Board. The company changed its presentation currency from Canadian dollars to U.S. dollars in 2022. The change in presentation currency was made to improve investors' ability to compare the company's financial results with other publicly traded businesses in the industry. In making the change to a U.S.-dollar presentation currency, the company followed the guidance in international accounting standard 21 (the Effects of Changes in Foreign Exchange Rates) and has applied the change retrospectively to all prior periods as if the new presentation currency had always been the company's presentation currency.

Operating expenses for the three months ended June 30, 2023, were $3,353,060 compared with $4,963,622 during the same period in 2022.

For the three months ended June 30, 2023, the net loss was $4,904,919 compared with $286,163 during the same period in 2022.

For the six months ended June 30, 2023, cash used in operating activities was $7,180,611 compared with $7,883,265 for the same period in 2022.

As June 30, 2023, cash and cash equivalents were $20,889,719.

For detailed financial results, please refer to Perimeter's SEDAR+ filings and the company's website.

Conference call

The company will host a conference call and live audio webcast today, Tuesday, Aug. 29, 2023, at 5 p.m. Eastern Time, to discuss its second quarter 2023 results and to provide a corporate update. To participate in the call, please dial 1-877-704-4453 or 1-201-389-0920 for international callers, and provide conference ID No. 13740570. The conference call will also be broadcast live on-line through a listen-only webcast, which will be posted in the investors section of the company's website. The webcast will be archived on the company's investor relations web page for at least 90 days. A telephonic playback of the conference call will be available for 14 days after the conference call by calling 1-844-512-2921 or 1-412-317-6671 and referencing conference ID 13740570. The above-listed dates and times are subject to change.

About Perimeter Medical Imaging AI Inc.

Based in Toronto, Canada, and Dallas, Tex., Perimeter (TSX Venture Exchange: PINK) (OTC: PYNKF) (Frankfurt Stock Exchange: 4PC) is a medical technology company driven to transform cancer surgery with ultrahigh-resolution, real-time, advanced imaging tools to address areas of high unmet medical need. Available across the United States, its Food and Drug Administration-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 its next-generation artificial intelligence technology that is currently being evaluated in a pivotal clinical trial, with support from a grant of up to $7.4-million (U.S.) 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.

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