SHINE year-end report highlights construction progress, strong investor confidence
SHINE Medical Technologies LLC today provided a strong 2019 year-end report, including significant progress with the construction of its medical isotope production facility, a robust year of fundraising and commercial advances in key geographic and product markets.
"2019 was SHINE's most productive, successful year yet, driven by an incredibly dedicated team that moved the company forward in important ways," said Greg Piefer, founder and CEO of SHINE. "Our team's progress on the construction of our production facility is the strongest signal to date that SHINE will play a big role in solving the global shortage of molybdenum-99."
Strong construction progress
SHINE broke ground for its medical isotope production facility in Janesville, Wis., last May. Excavation for the production facility began last September and the first foundational concrete was poured later in the fall. Concrete that forms the structure of the facility continues to be poured.
There are only four major facilities in the world that produce Mo-99, one of the most important isotopes relied on for heart stress tests, cancer staging and other medical applications. Chronic shortages of Mo-99 routinely and significantly affect the diagnosis and treatment of patients around the world.
When SHINE's production facility begins producing Mo-99 at commercial scale in 2022, the facility will play a significant role in alleviating the worldwide shortages and their harmful impacts on patients. It will be capable of supplying more than one-third of the global patient need for Mo-99.
Continued investor support
Both new and long-time investors continued to express confidence in the company's direction and progress last year. SHINE raised $125 million during 2019, including $50 million from leading global investment firm Oaktree Capital Management. The financing in part supports SHINE's ongoing construction project and its work to commercialize diagnostic and therapeutic isotopes, including Mo-99 and lutetium-177 (Lu-177). The SHINE fundraising total includes an award of $15 million from the federal government.
"We are grateful for the strong, ongoing support of both our new high-quality institutional investors and the many early-stage investors who continue to support the company and provide additional capital," said Todd Asmuth, SHINE's president and CFO. "During 2019, we were excited to welcome Oaktree Capital Management to our growing list of top-tier institutional investors. Oaktree has broad expertise in complex infrastructure projects like our production facility. It joined Deerfield Management, a leading health care investment firm, as one of our key partners. We also are appreciative of our partnership with the federal government. Its commitment to SHINE coupled with investments from both new and old investors were essential to our solid year of progress and will help us to boldly advance our plans as we move forward."
Therapeutics division focused on fundamental change to cancer treatment
The company created SHINE Therapeutics last October. The division is focusing initially on the development and commercialization of Lu-177. The isotope has the potential to fundamentally change the way cancer patients are treated. Studies have shown improved patient survival with Lu-177 treatment of neuroendocrine tumors and prostate cancer in patients who do not respond to other treatments. Lu-177 directly irradiates cancer cells after being delivered to the cancer site by a targeting molecule.
Last May, SHINE entered an agreement with IOCB Prague that provides the company with an exclusive global license to a novel technology that enables SHINE to produce therapeutically desirable non-carrier-added Lu?177.
SHINE also achieved a number of other key milestones, including the following:
Commercial
- In September, SHINE established a direct presence in Europe with the appointment of industry expert Harrie Buurlage as SHINE's vice president of European operations. Mr. Buurlage is leading the company's effort to site, construct and run an isotope production facility in Europe. When the European facility begins production, SHINE will be capable of producing more than two-thirds of the global patient demand for Mo-99.
Corporate
- Paul Ryan, the former Speaker of the U.S. House of Representatives, joined the company's board of directors in August. Mr. Ryan brings decades of national and international experience with complex health care, business, energy and other issues to SHINE's board.
Production demonstrations
- During 2019, the company performed demonstrations of the neutron generator that will be at the heart of the production facility. Last June, SHINE and its sister company Phoenix LLC tested the first production-ready neutron generator over 5½ days, achieving greater than 99 percent uptime. The two companies last October announced that they had achieved a new world record for a nuclear fusion reaction in a steady-state system. The company's production facility will house eight of these neutron generators when it is completed.
Regulatory
- The U.S. Nuclear Regulatory Commission began its official review of SHINE's operating license application after accepting the application last October. SHINE submitted its operating license application to the commission last July. The submission of the application signaled the start of the company's transition from the design and engineering phase to the construction and delivery phase.
"SHINE expects to continue its strong progress during 2020," Piefer said. "We will complete the construction of our main production building in Janesville; continue to develop lutetium-177, our first therapeutic product; and work to identify the site of our European facility. These and other 2020 goals support the continued advancement of SHINE's purpose: to improve the world with nuclear technology with a commercially practical, growth based approach."
J.P. Morgan Healthcare Conference
Members of SHINE's management team will be attending the annual J.P. Morgan Healthcare Conference. The conference is being held Jan. 13-16 in San Francisco. The SHINE team expects to meet with investors during the conference.
About SHINE Medical Technologies LLC
Founded in 2010, SHINE is a development-stage company working to become a manufacturer of radioisotopes for nuclear medicine. The SHINE system uses a patented, proprietary manufacturing process that offers major advantages over existing and proposed production technologies. It does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation's existing supply chain for Mo-99. In 2014, SHINE announced the execution of Mo-99 supply agreements with GE Healthcare and Lantheus Medical Imaging. In 2015, with the help of Argonne National Laboratory, GE Healthcare demonstrated that SHINE Mo-99 can act as a drop-in replacement for reactor-based Mo-99. In 2016, SHINE received regulatory approval from the Nuclear Regulatory Commission to construct its production facility. The company began construction of the facility in the spring of 2019. SHINE's application to operate the facility is under review by the commission. For more information, please visit www.shinemed.com.
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