POINT Biopharma Confirms No Delays to SPLASH Trial Due to Recent Global Lutetium Supply Interruption
POINT Biopharma Global Inc. (PNT) announced that recent geopolitical events and a reactor shutdown in Europe have not impacted its trial timelines or 2022 business outlook. Point's CEO emphasized the strength of their radioisotope supply chain, which has proven resilient amid industry challenges. The company continues recruitment for its Phase 3 SPLASH trial evaluating PNT2002 for treating metastatic castration-resistant prostate cancer, expecting to report top line data by mid-2023. POINT’s robust supply chain management is highlighted as a key factor in maintaining operational stability.
- No disruption to trial timelines despite reactor shutdown in Europe.
- Strong supply chain management validated during industry challenges.
- Ongoing recruitment for Phase 3 SPLASH trial, with top line data expected mid-2023.
- None.
POINT’s industry-leading radioisotope supply chain enabled company to avoid delays
INDIANAPOLIS, March 22, 2022 (GLOBE NEWSWIRE) -- POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today affirmed that a recent reactor shutdown in Europe and current geopolitical events concerning Russia and Ukraine have not impacted the Company’s trial timelines or the Company’s 2022 business outlook.
“One of the founding principles of POINT is to have the most robust supply chain in the radiopharmaceutical industry, from neutron to patient.” said Dr. Joe McCann, CEO of POINT Biopharma. “The significant challenges with lutetium-177 supply earlier this year due to an unplanned shutdown of a major reactor in Europe provided an opportunity to demonstrate the robustness of our supply chain. Today I am confirming that the shutdown did not have a negative impact on any aspect of our business, validating our focus on supply chain. I am proud of my team’s success, and I am looking forward to seeing them continue to make POINT the most dependable radiopharmaceutical partner of physicians and patients globally.”
POINT’s management team has long-standing relationships with leading external partners for lutetium-177 (177Lu) supply, with each partner having their own diverse networks for neutron irradiation, minimizing the impact of single reactor outages. Establishing redundancy across every key business area is a pillar of POINT’s value proposition to physicians and patients, as it is not possible to forecast reactor-related irradiation shortages and other similar radiopharmaceutical supply chain disruptions.
Recruitment continues for the Company’s Phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), currently enrolling patients across 32 sites in North America and Europe. Site activations in all jurisdictions remain ongoing to expedite accrual, and the Company continues to expect to report top line data from SPLASH mid-2023.
About POINT Biopharma Global Inc.
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 is transforming precision medicine by combining a portfolio of best-in-class radio-pharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes like actinium-225 and lutetium-177. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.com/. Information about POINT Biopharma Global Inc.’s Phase 3 SPLASH trial for metastatic castrate resistant prostate cancer (mCRPC) patients can be found at https://www.splashtrial.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, the outcome of any legal proceedings that may be instituted against POINT following the closing of the business combination, the risk that the business combination disrupts current plans and operations, the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of POINT to grow and manage growth profitably and retain its key employees, the impact of COVID-19 on POINT’s business, the ability to maintain the listing of POINT’s 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 POINT's S-1 registration statement filed with the SEC on July 30, 2021. Most 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.
Contact:
Ari Shomair
Chief of Staff
media@pointbiopharma.com
(317) 543-9957
Investor Relations Contact:
Daniel Pearlstein
Associate Director, Corporate Strategy
investors@pointbiopharma.com
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