March 27, 2023 – INDIANAPOLIS, INDIANA – POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update.
“POINT continued to make significant progress in 2022, enabled by our company's deep expertise in radioligands and our vertically integrated, highly differentiated radioligand platform,” said Joe McCann, Ph.D., Chief Executive Officer of POINT Biopharma. "For PNT2002, POINT's lutetium-177-labelled PSMA-targeted program, we both completed enrollment of the randomization phase of our phase 3 trial and also entered into a strategic collaboration for its commercialization with Lantheus, a leader in PSMA PET imaging. I am proud of our agreement with Lantheus as it positions PNT2002 and PNT2003 for maximum commercial success and validates the value of our radioligand platform. In December 2022, we received $260 million in upfront payments from Lantheus and have the potential to receive an additional $1.8 billion in future milestone payments as well as meaningful double-digit royalties. These upfront payments, together with net proceeds of $130 million from our successful follow-on financing in September 2022, strengthen our balance sheet, starting 2023 with over $540 million in cash, cash equivalents and investments. We are in the fortunate position to be able to expand our pipeline, and to strengthen our manufacturing and supply chain capabilities."
"We also made meaningful progress in 2022 pushing forward our pipeline of next generation radioligand therapies," Dr. McCann continued. "PNT2004, our pan-cancer FAP-α-targeted program, entered its first in-human phase 1 clinical trial. We advanced PNT2001, our next-generation actinium-225 PSMA-targeted program, to enable the initiation of our phase 1 study later this year. Finally, on radioligand manufacturing and supply, a core competency of POINT, we made significant headway on the construction of our n.c.a. lutetium-177 production line, which we expect to come online by the end of this year. Thank you to the patients, health care professionals, partners, and investors who have all contributed to our continued success. We remain laser-focused on delivering the next generation of radioligands."
Business Highlights and Upcoming Milestones
PNT2002: 177Lu-labelled PSMA-targeted radioligand therapy, and PNT2003: 177Lu-labelled somatostatin-targeted radioligand therapy
In December 2022, we closed our previously announced strategic collaboration and exclusive license agreements with Lantheus Holdings, Inc. (NASDAQ: LNTH) for exclusive worldwide rights for PNT2002 and PNT2003, excluding certain territories (Japan, South Korea, Singapore, Indonesia, and China including Hong Kong, Macau and Taiwan). In December 2022, we received a $260 million upfront payment and could receive an additional payment of up to a combined $280 million upon U.S. regulatory approval for both PNT2002 and PNT2003, by the terms of our agreement with Lantheus.
In December 2022, the target enrollment for randomization of the phase 3 SPLASH trial was completed on schedule, with more than 390 participants randomized across 55 SPLASH trial sites in North America, Europe, and the U.K. We expect to report top line data from SPLASH in the second half of 2023.
In late 2022, we received the OZM-067 clinical trial data sets from the trial sponsor. POINT will facilitate the analysis of the data sets. As per the strategic collaboration and exclusive license agreement, Lantheus will be responsible for all subsequent development of the asset post initial regulatory filings within the U.S., and for all development efforts in their territories.
PNT2004: fibroblast activation protein-α (FAP-α) inhibitor-targeted radioligand therapy
We initiated our phase 1 FRONTIER clinical trial for PNT6555 in July 2022 in Canada using a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a n.c.a. 177Lu-based PNT6555 therapeutic agent. FRONTIER's clinical protocol evaluates PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.
Enrollment in cohort 2 of FRONTIER began in December 2022 and we expect enrollment in cohort 3 to begin in the second quarter of 2023. A total of six participants have been dosed with 177Lu-PNT6555 to date. We anticipate data from the full FRONTIER study to be available in the first half of 2024.
Manufacturing & Supply Chain Updates:
Our Indianapolis manufacturing facility began production of n.c.a. 177Lu-PNT2002 clinical trial product in January 2022. In addition to our manufacturing facility in Indianapolis, Indiana, we also maintain active relationships with radiopharmaceutical contract manufacturers and isotope suppliers across multiple geographies. We expect the line for our in-house production of n.c.a. 177Lu to come online by the end of 2023.
Fourth Quarter and Full Year 2022 Financial Results
Cash Position: Cash, cash equivalents and investments were $541.3 million as of December 31, 2022, which is anticipated to fund operations into fiscal 2026.
Net Income / Loss: Net income was $163.3 million, or $1.55 and $1.53 net income per basic and diluted share, respectively, for the quarter ended December 31, 2022. Net loss was $14.2 million, or $0.16 net loss per basic and diluted share, for the quarter ended December 31, 2021. Net income was $98.3 million, or $1.04 and $1.02 net income per basic and diluted share, respectively, for the year ended December 31, 2022, as compared to a net loss of $45.9 million, or $0.62 net loss per basic and diluted share, for the same period in 2021.
Research and Development (R&D) Expenses: R&D expenses were $27.9 million for the quarter ended December 31, 2022, as compared to $9.5 million for the same period in 2021. R&D expenses were $82.1 million for the year ended December 31, 2022, as compared to $33.5 million for the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $7.3 million for the quarter ended December 31, 2022, as compared to $4.6 million for the same period in 2021. G&A expenses were $19.0 million for the year ended December 31, 2022, as compared to $12.0 million for the same period in 2021.
About POINT Biopharma
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the benefits of the recently completed business combination, as well as statements about the potential attributes and benefits of POINT’s product candidates and the format and timing of POINT’s product development activities and clinical trials. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, our ability to grow and manage our growth profitably and retain our key employees, the impact of COVID-19 on our business, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, our ability to obtain funding for our operations, our the ability to maintain the listing of our common stock on the NASDAQ, changes in applicable laws or regulations, the possibility that POINT may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described in our Annual Report on Form 10-K filed with the SEC on March 27, 2023. Many of these factors are outside of POINT’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
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