First European Union Patient Dosed with 177Lu-PNT2002 in the Phase 3 SPLASH Trial

Rhea-AI Summary

POINT Biopharma has initiated randomization in its Phase 3 SPLASH trial for pre-chemo metastatic castration-resistant prostate cancer (mCRPC) across North America and Europe. The first patient in the EU has been dosed, with a total of 37 sites now enrolling. The trial is utilizing ¹⁷⁷Lu-PNT2002, a PSMA-targeted radioligand, with top-line data expected mid-2023. This milestone marks significant progress since the trial’s inception in September 2021, demonstrating POINT's commitment to innovating cancer treatments.

Positive

• Initiation of randomization in Phase 3 SPLASH trial across North America and Europe.
• First patient dosed in the EU, expanding trial participation.
• 37 trial sites currently enrolling patients.
• Top-line data expected mid-2023, indicating potential for positive trial outcomes.

Negative

• Dependence on timely recruitment and trial completion by end of 2022.
• Regulatory uncertainties that may affect trial outcomes and timelines.

POINT Biopharma’s Phase 3 SPLASH trial in pre-chemo metastatic castration-resistant prostate cancer (mCRPC) is now randomizing in the US, Canada, and Europe

Sites initiated in France, Sweden, Netherlands, and the UK, with randomization in each expected this summer

INDIANAPOLIS, April 26, 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 announced the first patient in the European Union (EU) has been dosed in the Phase 3 SPLASH trial (NCT04647526). The SPLASH trial is investigating the use of ¹⁷⁷Lu-PNT2002, a PSMA-targeted radioligand, in pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC), with entry criteria including a positive PSMA-PET scan with either ⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL.

The SPLASH trial began randomization in North America in September 2021, and a total of 37 trial sites across North America and Europe are currently enrolling patients. Site activations in remaining jurisdictions continue to further accelerate trial recruitment. The Company continues to expect to report top line data from SPLASH mid-2023.

“I’m pleased with our team’s consistent execution of the SPLASH trial,” said Dr. Joe McCann, CEO of POINT Biopharma. “In two years, we’ve gone from a pre-IND meeting with the FDA to dosing patients in multiple countries, and I’m proud of our team for realizing this achievement. We remain on track to complete recruitment by the end of this year, and to disclose efficacy and safety data from the 27-patient lead-in in the second half of 2022.”

In February 2022, the Company announced publication of the first data from the SPLASH trial, dosimetry results from the lead-in cohort. The findings presented by Dr. Jean-Mathieu Beauregard concluded that “PNT2002 has a favorable and safe dosimetry profile in the patient population and dose regimen being studied." To provide additional context on interpreting dosimetry, the Company also hosted an investor education event titled “Introduction to Dosimetry for Radiopharmaceuticals” shortly after the release of the data. The 30-minute educational webinar was led by Dr. Ana Kiess, M.D., Ph.D., Assistant Professor of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins Hospital, and provides more context into interpreting dosimetry results. A replay of the webinar and the slides are available to download at https://hub.pointbiopharma.com/dosimetry.

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 radiopharmaceutical 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

FAQ

What is the SPLASH trial by POINT Biopharma (PNT)?

The SPLASH trial is a Phase 3 clinical study investigating the efficacy of ¹⁷⁷Lu-PNT2002 for treating metastatic castration-resistant prostate cancer (mCRPC) before chemotherapy.

When was the first patient dosed in the SPLASH trial?

The first patient in the European Union was dosed in April 2022.

What are the expected outcomes of the SPLASH trial for PNT?

Top-line data from the SPLASH trial is expected to be reported in mid-2023.

How many sites are involved in the SPLASH trial for PNT?

There are currently 37 trial sites enrolling patients in the SPLASH trial.