Evergreen Theragnostics Raises $26M in Capital to Aid Commercialization Efforts for the Ga-68 DOTATOC Diagnostic Kit

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Evergreen Theragnostics announced that it has successfully completed a $26 million capital raise, with investors such as Petrichor and LIFTT. According to the company, proceeds will go toward advancing its radiopharmaceutical discovery pipeline into clinical trials, supporting commercialization of its Ga-68 DOTATOC diagnostic kit, and augmenting its Contract Development and Manufacturing Organization (CDMO) capabilities. With the new capital, Evergreen is preparing to launch Octevy, a diagnostic agent, once approved by the FDA. Additionally, it plans to start clinical trials for its theragnostic pair for small cell lung cancer (SCLC), featuring Lutetium-177 (177Lu) and Gallium-68 (68Ga) EVG-321.¹

"We have been advancing our discovery pipeline and are excited to take the next step in development," said James Cook, CEO, Evergreen Theragnostics, in a press release. "As we continue to work with the FDA on approval of our Ga-68 DOTATOC diagnostic kit, this new funding will enable us to rapidly progress our novel theragnostic pair, EVG-321, into clinical trials. In addition, our CDMO business is continuing to build momentum as we bring on new customers and expand our efforts with existing ones. We appreciate the trust given to us by our existing and new shareholders in advancing our priorities."

In March of last year, Evergreen announced the completion of a $15 million Series B capital raise. As a result, it launched a discovery unit and began supply chain preparations for the introduction of Ga-68 DOTATOC.²

"Evergreen is focused on improving the available options for cancer patients through radiopharmaceuticals. We do so by ensuring product availability for clinical trials through our core CDMO business, and in new ways such as the development of Ga-68 DOTATOC and the establishment of Evergreen Discovery," said Cook, in a press release. "We are glad to have secured this important funding to enable our continued pursuit of these goals."

Evergreen first submitted a New Drug Application (NDA) for the Ga-68 DOTATOC Kit to the FDA toward the end of 2022, focusing on imaging of neuroendocrine tumors using positron emission tomography.³

"Gallium-68 DOTATOC imaging has been clinically used in Europe for well over a decade," said Cook, in a press release. "The University of Iowa took an important step in 2019 by gaining FDA approval for their own NDA for Gallium-68 DOTATOC, produced locally at the University of Iowa. If approved, this NDA will build on that by making Ga-68 DOTATOC imaging available nationwide for neuroendocrine tumor patients, in the form of an easy-to-use kit for radiopharmacies. We thank the University of Iowa for leading the way in this space, as well as for their support and contribution to this application."

According to the American Cancer Society, lung cancer is the second most common form of cancer in both genders in the United States. Based on its estimated for 2024, there were around 234,580 new cases of lung cancer, with 125,070 deaths. Further, it is considered to be is the leading cause of death by cancer in the United States, accounting for 20% of cancer-related fatalities in the United States annually.⁴

References

1. Evergreen Theragnostics Completes $26M Capital Raise to Advance Novel Radiopharmaceutical Pipeline into the Clinic, Prepare for First Commercial Product Launch, and Expand Industry-Leading CDMO Services. PR Newswire. April 16, 2024. Accessed April 16, 2024. https://www.prnewswire.com/news-releases/evergreen-theragnostics-completes-26m-capital-raise-to-advance-novel-radiopharmaceutical-pipeline-into-the-clinic-prepare-for-first-commercial-product-launch-and-expand-industry-leading-cdmo-services-302115657.html

2. Evergreen Theragnostics Completes $15M Series B, Launches Discovery Unit, and Prepares Ga-68 DOTATOC Supply Chain. PR Newswire. March 13, 2023. Accessed April 16, 2024. https://www.prnewswire.com/news-releases/evergreen-theragnostics-completes-15m-series-b-launches-discovery-unit-and-prepares-ga-68-dotatoc-supply-chain-301768310.html

3. Evergreen Theragnostics Submits New Drug Application for Gallium-68 DOTATOC Kit with US FDA. PR Newswire. December 12, 2022. Accessed April 16, 2024. https://www.prnewswire.com/news-releases/evergreen-theragnostics-submits-new-drug-application-for-gallium-68-dotatoc-kit-with-us-fda-301699743.html

4. Key Statistics for Lung Cancer. American Cancer Society. Accessed April 16, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html#:~:text=Key%20Statistics%20for%20Lung%20Cancer,How%20common%20is%20lung%20cancer%3F