Telix and Mauna Kea Technologies to Expand Collaboration in Urologic Oncology Surgery

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13 Nov, 2023, 08:20 GMT

MELBOURNE, Australia and PARIS, Nov. 13, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) and Paris-based Mauna Kea Technologies (Euronext Growth: ALMKT, Mauna Kea), today announce an expansion of the IRiS (Imaging and Robotics in Surgery) Alliance^[1]through a strategic €6.0 million (AU$9.6 million^[2]) investment to develop new hybrid pharmaceutical-device products through the combination of Telix's cancer-targeting agents with Mauna Kea's Cellvizio^® surgical endomicroscopy platform. Telix's investment in Mauna Kea will further support the development of advanced imaging techniques for minimally invasive (laparoscopic and robotic) surgery, with a specific focus on urologic oncology.

Mauna Kea is a leading medical device company pioneering the development of real-time intraoperative visualisation of cancer tissue during surgery. Mauna Kea's Cellvizio confocal laser endomicroscopy (CLE) in vivo cellular imaging platform has received U.S. Food and Drug Administration (FDA) approval and is CE Marked for a range of applications.^[3] Cellvizio's regulatory approval landscape and broad clinical experience make it an ideal platform to explore applications of endomicroscopy combined with radiopharmaceutical and fluorescence imaging techniques to build a comprehensive intra-operative imaging toolbox for urology applications. This strategic investment is synergistic with Telix's current diagnostic radiopharmaceutical portfolio as well as its recent Lightpoint and Dedicaid GmbH acquisitions.^{[4], [5]}

When used pre-operatively, Telix's radiopharmaceutical imaging agents such as TLX591-CDx (Illuccix^®) or TLX250-CDx (Zircaix^®)^[6]potentially enable improved surgical planning to determine the location and extent of disease. Lightpoint's SENSEI^®, a radio-guided surgical probe works in conjunction with suitable cancer-seeking radiotracer agents to enable the intra-operative detection of cancer during a surgical intervention to help accurately answer the question, "where is the cancer?" In a complementary fashion, Mauna Kea's Cellvizio platform enables highly localised tissue visualisation through endomicroscopic fluorescence detection to potentially define and confirm surgical margins in real-time.

Reflecting a shared commitment to building a long-term clinical and commercial partnership, Telix will acquire 19.33% of Mauna Kea's ordinary shares in a reserved private placement with a closing date of 17 November 2023.

Sacha Loiseau, Ph.D., Chairman and CEO of Mauna Kea Technologies, commented: "Cellvizio's in vivo cellular visualisation platform is an enabling technology across a range of clinical indications that can use molecular imaging to guide surgical intervention in real-time. It is very complementary to Telix's portfolio of late-stage radiopharmaceutical diagnostics, surgical and AI tools, which combined may create a powerful suite of solutions to help surgeons perform more precise tumour resections and address some of the most complex issues in uro-oncologic treatment. I am pleased to welcome Telix, a global leader in theranostic radiopharmaceuticals and precision medicine as a shareholder and strengthen our commitment to bring our shared vision to fruition."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix added, "We are committed to expanding this partnership, which brings together the cutting-edge technologies in targeted radiation, radio-guided surgery and real-time in vivo cellular imaging our respective companies are developing. This further enhances our differentiated and innovative offering in urology and continued commitment to engaging with key opinion leaders in the field to deliver significant improvements in surgical techniques and clinical outcomes, in order to improve the lives of the patients we serve."

Key deal terms

Pursuant to a subscription agreement entered into between the parties on 13 November 2023, Telix has agreed to purchase 11,911,852 new ordinary shares of Mauna Kea, at €0.5037 per share (AU$0.85), reflecting a 10% premium over the preceding 10-day VWAP^[7] before signing. Following closing (on 17 November 2023), Telix will own 19.33% of the share capital and 19.01% of the voting rights of Mauna Kea.

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio^®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualisation which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn.

Telix's lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),^[8] by the Australian Therapeutic Goods Administration (TGA),^[9] and by Health Canada.^[10]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Legal Notices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website.

[1] Telix ASX disclosure 16 December 2020.

[2] AUD/EUR exchange rate of 0.60

[3] Mauna Kea media release, 3 March 2020.

[4] Telix ASX disclosure 1 November 2023.

[5] Telix ASX disclosure 27 April 2023.

[6] Nominated brand name for TLX250-CDx subject to final regulatory approval.

[7] Volume-weighted average price.

[8] Telix ASX disclosure 20 December 2021.

[9] Telix ASX disclosure 2 November 2021.

[10] Telix ASX disclosure 14 October 2022.

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