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

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

Summary

Australia's Telix expands urology treatment pipeline with US$20 million acquisition of UK's Lightpoint Medical

• Australian nuclear medicine company Telix Pharmaceuticals will acquire UK-based Lightpoint Medical, a medical device company specializing in intraoperative detection of targeted radiopharmaceuticals   
• Telix Is a biopharmaceutical company focused on developing diagnostic and therapeutic radiopharmaceuticals  
• Lightpoint will become a new unit within Telix to support development of its medical device and software technology
• Lightpoint's Sensei business will be integrated into Telix and operate as new surgeon-focused unit
• Telix will pay US$20 million up front and a further US$15 million on achievement of development milestones

ASX Announcement

Melbourne (Australia) – 21 June 2023. 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 2021⁴ to jointly develop SENSEI with Telix’s investigational PSMA⁵-targeting SPECT⁶ 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."

Deal terms and conditions

This acquisition is being implemented by the purchase of Lightpoint Medical’s wholly owned subsidiary, Lightpoint Surgical Limited, which will own Lightpoint Medical’s business, assets and operations until completion.

The purchase price is comprised of US$20 million (AU$29 million¹⁰) upfront, paid in equity at completion, and a further US$15 million (AU$22 million¹¹) earn-out which is payable in cash or equity, at Telix’s election, upon achievement of certain milestones relating to the ongoing development and commercialisation of the SENSEI probe.¹²

Telix will issue ordinary shares to the vendor within its Listing Rule 7.1 placement capacity as consideration for the acquisition. Upfront and any earnout equity will be subject to customary escrow conditions.¹³

Completion of the transaction is subject to customary conditions, including regulatory approvals, with completion expected to occur within three months. The ongoing operational cost of the transaction does not represent a material deviation from planned 2023 R&D and commercial expenditure.

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 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 (@TelixPharma) and LinkedIn.

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),¹⁴ and by the Australian Therapeutic Goods Administration (TGA),¹⁵ and by Health Canada.¹⁶ Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.¹⁷

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

Telix Investor Relations

Ms. Kyahn Williamson

Telix Pharmaceuticals Limited

SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com