Telix to Expand Late-Stage Urologic Pipeline with Acquisition of Lightpoint Medical

MELBOURNE, Australia, June 21, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire Lightpoint Medical and its SENSEI® radio-guided surgery business. Lightpoint Medical is a United Kingdom-based medical device company specialising in the intra-operative detection of targeted radiopharmaceuticals.

SENSEI is an ultra-miniature robotic gamma probe for intracavital use that is able to provide radiopharmaceutical-based surgical guidance ("radio-guided surgery") by enabling the intra-operative detection of cancer in real time. Telix's initial commercial objective is to align SENSEI with Telix's Illuccix®/TLX599-CDx^[1] programs for prostate cancer. Additionally, there is considerable scope to expand into other urologic and non-urologic malignancies. Lightpoint also has innovative capabilities in artificial intelligence (AI) for surgical guidance that will complement Telix's own AI program.

This highly strategic and synergistic transaction broadly strengthens Telix's capabilities in deploying molecular imaging in the surgical setting. The acquisition will further enhance and differentiate Telix's innovation position and product depth in urology by enabling targeted radiation to be harnessed across the entire continuum of cancer patient care, from initial diagnosis and staging, to surgical intervention and therapeutic use.

SENSEI has attained a marketing authorisation in the United States, having been registered with the U.S. Food and Drug Administration (FDA) since September 2020. SENSEI has also attained a Conformité Européenne (CE) Mark for use in the European Economic Area (and other applicable countries) in January 2021 for intra-operative detection of sentinel lymph nodes and cancer metastasis via the lymphatic system, supporting broad clinical use of the product.^[2] The SENSEI probe is currently the only gamma probe validated for use with the Intuitive Surgical DaVinci® robotics system.^[3]

Telix initially established a strategic collaboration agreement with Lightpoint in August 2021^[4] to jointly develop SENSEI with Telix's investigational PSMA^[5]-targeting SPECT^[6] imaging agent TLX599-CDx for prostate cancer. The Lightpoint SENSEI business will be integrated into Telix and operate as a new surgeon-focused business unit, driving the ongoing development of SENSEI combined with Telix's pharmaceutical pipeline. This new business unit will also support development of Telix's other related medical device and software technologies, such as Telix's recently acquired artificial intelligence platform.^[7]

In the U.S. alone, an estimated 288,300 men will be diagnosed with prostate cancer in 2023,^[8] with approximately one-third (96,100) receiving radical prostatectomy. At least 85 percent of these performed robotically.^[9] The use of molecular imaging in the operating theatre has the potential to drive a paradigm shift in the surgical treatment of cancer in terms of throughput and patient outcomes.

Dr Colin Hayward, Chief Medical Officer of Telix said, "PSMA-targeted imaging is transforming the detection of prostate cancer. With radio-guided surgery we can harness the targeting power of PSMA to precisely guide surgery and create a holistic 'PSMA toolkit' to detect, manage and treat this disease. This is in line with our vision to continue to innovate and partner with physicians at every step of the patient journey. Small, flexible gamma probes that can be used in the operative field while conducting robotic or laparoscopic surgery is a powerful innovation."

Dr Christian Behrenbruch, Managing Director and Group CEO of Telix said, "The transaction with Lightpoint brings a compelling commercial-stage asset to Telix that has the potential to transform the use of radiopharmaceuticals in the interventional setting, with commensurate impact on Telix's market share for Illuccix. This acquisition also brings a highly talented team to drive development of this asset and will leverage the commercial infrastructure we have built for Illuccix to further deepen our relationship with our customers."

Founder and CEO of Lightpoint Medical, Dr David Tuch said, "We are thrilled to be joining forces with Telix to propel the development of radio-guided surgery. This acquisition brings numerous benefits to our surgeon users including enhanced access to the SENSEI technology and a continuum of PSMA-based detection and treatment options. We look forward to working with Telix to shape the future of targeted cancer treatment."

Visit www.telixpharma.com^[1] to view or download Telix's ASX disclosure, with further information including deal terms and conditions.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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 need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Visit www.telixpharma.com^[2] 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 Twitter^[3] (@TelixPharma) and LinkedIn^[4].

TLX599-CDx has not received a marketing authorisation in any jurisdiction. 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),^[10] and by the Australian Therapeutic Goods Administration (TGA),^[11] and by Health Canada.^[12] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.^[13]

About Lightpoint Medical Ltd.

Lightpoint Medical is a technology leader in precision-guided robotic cancer surgery. We develop and market miniaturised imaging and sensing tools for advanced intra-operative cancer detection. Our mission is to improve the lives of people with cancer by transforming the efficacy of robotic surgery. Lightpoint is headquartered in the U.K. with offices in Cambridge, Massachusetts; Barcelona; and Amsterdam. Visit: www.lightpointmedical.com and www.senseisurgical.com^[5][6]

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[7]

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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.

©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). 

^{[1] 99mTc-HYNIC-iPSMA (TLX599-CDx).[2] Lightpoint Medical media release 20 January 2021.[3] Registered trademark of Intuitive Surgical Inc.[4] Telix ASX disclosure 23 August 2021.[5] Prostate-specific membrane antigen.[6] Single photon emission computed tomography.[7] Telix ASX disclosure 27 April 2023.[8] Oberlin et al., Urol Oncol. 2016.[9] Harvard Medical School, 2022.[10] Telix ASX disclosure 20 December 2021.[11] Telix ASX disclosure 2 November 2021.[12] Telix ASX disclosure 14 October 2022.[13] Telix ASX disclosure 3 April 2023.}

References

1. ^{^} www.telixpharma.com (www.telixpharma.com)
2. ^{^} www.telixpharma.com (www.telixpharma.com)
3. ^{^} Twitter (twitter.com)
4. ^{^} LinkedIn (www.linkedin.com)
5. ^{^} www.lightpointmedical.com (www.lightpointmedical.com)
6. ^{^} www.senseisurgical.com (www.senseisurgical.com)
7. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)