On May 13, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Point Biopharma, MAY 13, 2022, View Source [SID1234614535]).
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"There were two very significant milestones for POINT in the first quarter of 2022," said Dr. Joe McCann, CEO of POINT Biopharma. "First, we began supplying doses for the SPLASH trial out of our company-owned manufacturing facility. Second, we reported very encouraging dosimetry data from our Phase 3 SPLASH trial lead-in phase which is evaluating PNT2002 in pre-chemotherapy metastatic castration-resistant prostate cancer (mCRPC). The data positions us well as we continue with the randomization phase of SPLASH. The reason these milestones are very significant is they place POINT in the extremely small number of companies which have successfully manufactured their own radioligands, for their own Phase 3 trial. Combined with the upcoming advancement of our pan-cancer FAP-targeting program PNT2004 into the clinic this summer, POINT’s radioligand platform has the potential to be transformative for cancer care in a variety of indications with high unmet need."
Recent Developments and Upcoming Milestones
Pipeline Updates
PNT2002: 177Lu-based PSMA targeted radiopharmaceutical
In February 2022, the Company announced publication of the dosimetry results from the lead-in cohort of the Phase III SPLASH trial evaluating PNT2002 for the treatment of mCRPC at the 2022 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Mid-Winter & American College of Nuclear Medicine (ACNM) Annual Meeting. 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." A link to the Abstract can be found in the Investors section of the company’s website found here: View Source
In March 2022, the Company hosted a virtual education event titled "Introduction to Dosimetry for Radiopharmaceuticals" led by a key opinion leader in the field, Dr. Ana Kiess, M.D., Ph.D. A replay of the event is accessible at View Source
In April 2022, the Company dosed its first European Union patient in the SPLASH trial. The SPLASH trial is currently enrolling patients across 42 sites in North America and Europe, and site activations all in jurisdictions remain ongoing to expedite accrual. The Company continues to expect to report top line data from SPLASH mid-2023.
PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical
The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program. The clinical trial for PNT2004 is expected to first initiate in Canada in summer 2022.
Manufacturing & Supply Chain Updates:
The Company’s Indianapolis manufacturing facility began supplying n.c.a. 177Lu PNT2002 to its SPLASH clinical trial in January 2022. The approximately 81,000 sq ft facility is licensed for alpha and beta emitting isotopes, and contains dedicated space for commercial-scale manufacturing. A virtual tour of the facility is accessible at View Source
In January 2022, the Company announced that it will receive 225Ac in 2022 from the U.S. Department of Energy Isotope Program to support its early-stage pipeline. The Company remains on track to launch its in-house n.c.a. 177Lu manufacturing program in 2023.
First Quarter 2022 Financial Results
Cash and Cash Equivalents: As of March 31, 2022, POINT had approximately $227.4 million in cash and cash equivalents, which is anticipated to fund operations into the first quarter of 2024.
Net Loss: Net loss was $16.4 million, or $0.18 net loss per share, for the quarter ended March 31, 2022, as compared to a net loss of $5.8 million, or $0.10 net loss per share, for the same period in 2021.
Research and Development Expenses: Research and development expenses were $12.5 million for the quarter ended March 31, 2022, as compared to $4.3 million for the same period in 2021.
General and Administrative Expenses: General and administrative expenses were $3.8 million for the quarter ended March 31, 2022, as compared to $1.5 million for the same period in 2021.