POINT Biopharma Confirms No Supply Shortages of 177Lu-PNT2002 for the SPLASH Trial
POINT Biopharma Global Inc. (NASDAQ: PNT) confirmed that its SPLASH clinical trial for the PSMA targeted 177Lu-PNT2002 program is on schedule, with no drug supply issues reported. The company emphasizes its robust supply chain capabilities to ensure timely delivery of radiopharmaceuticals. Recruitment for the Phase 3 trial is ongoing in North America and Europe, with top-line data expected by mid-2023. POINT's commitment to reliability and redundancy in manufacturing aims to address any potential disruptions in drug supply.
- SPLASH clinical trial remains on schedule and free from supply issues.
- Robust manufacturing facility and external partnerships enhance supply chain reliability.
- Active recruitment for Phase 3 SPLASH trial continues across multiple regions.
- None.
Clinical doses continue to be manufactured and shipped from the Company’s Indianapolis, Indiana facility
INDIANAPOLIS, May 05, 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 the SPLASH clinical trial for the PSMA targeted 177Lu-PNT2002 program remains on schedule and has not experienced any issues or delays related to clinical drug supply.
“Reliability is in our DNA,” said Dr. Joe McCann, CEO of POINT Biopharma. “POINT’s platform was designed from inception with a focus of ensuring the reliable delivery of next generation radiopharmaceuticals. The core reason reliability is so important to us is the narrow margin for error with radiopharmaceuticals; these drugs are manufactured just-in-time and only last for a few days. If you want patients to always receive their treatments, always on time, you need a redundant supply chain and manufacturing capabilities that can react in real time to unexpected changes. And that’s why we built POINT.”
POINT has built one of the industry’s most resilient medical isotope supply chains, which includes both external supply partners as well as internal isotope manufacturing capabilities. In addition to its manufacturing facility in Indianapolis, Indiana, POINT also maintains active relationships with radiopharmaceutical contract manufacturers to ensure redundant manufacturing capabilities. Establishing redundancy across every key business area is a pillar of POINT’s value proposition to physicians and patients, and to be resilient during rare reactor-related irradiation shortages and other similar radiopharmaceutical supply chain disruptions.
Recruitment and drug shipment to trial sites continue for the Company’s Phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC), currently enrolling patients across 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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