On May 15, 2023 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, 2023 and provided a business update (Press release, Point Biopharma, MAY 15, 2023, View Source [SID1234631753]).
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"As excitement in the clinical and commercial potential of radiopharmaceuticals grows, POINT continues to expand the breadth and depth of our next-generation radioligand platform," said Joe McCann, Ph.D., CEO of POINT Biopharma. "In Q1 we focused on addressing potential bottlenecks that could rate limit our progress. For our late-stage programs, we invested further in ensuring manufacturing scalability by securing additional reactor access necessary for the production of lutetium-177 isotope. For our early-stage programs, we addressed a key bottleneck in running future trials which utilize alpha-emitting isotopes by making a strategic investment in an actinium-225 manufacturer focused on commercial-scale production. With our strong balance sheet, we continue to focus on our core strengths – the discovery, development, and supply of next generation radioligands."
Business Highlights and Upcoming Milestones
Pipeline Updates
PNT2002: 177Lu-labelled PSMA-targeted radioligand therapy
Subsequent to the quarter, we announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC). Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs. Enrollment in PNT2002’s SPLASH trial (NCT04647526) is complete and top line data are expected in the second half of 2023.
PNT2004: fibroblast activation protein-α (FAP-α) targeted radioligand therapy
Enrollment in cohort 3 of the phase 1 FRONTIER trial (NCT05432193) began in the second quarter of 2023, and a total of seven 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.
PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy
PNT2001 builds on POINT’s first-generation, lutetium-based program with a next-generation ligand optimized for use with the alpha-emitting radioisotope actinium-225. We now anticipate a health authority submission for the program lead candidate 225Ac-PSMA-62 in Q4 2023, with the first patient expected for a phase 1 clinical trial in Q1 2024. To ensure consistent and reliable supply ahead of our first 225Ac in-human trial, we expanded our partnership with IONETIX and recently added another supplier in Eckert & Ziegler announced in April 2023.
Manufacturing & Supply Chain Updates
In February 2023, we entered into a Facility Agreement with University Health Network ("UHN") that authorizes us to access and utilize a 7,700 square foot, licensed research and development space with cGMP manufacturing suites in Toronto, Canada. The facility, now referred to as the POINT Institute for Radioligand Innovation ("PIRI"), will be used to develop and expand our pipeline of next-generation radioligands.
In May 2023, we announced a collaboration to create Ionetix Alpha Corp. (Ionetix-α). Ionetix-α, a new subsidiary of IONETIX Corp., is focused on near-term, commercial-scale production of GMP grade therapeutic isotopes, such as 225Ac. IONETIX has transferred its alpha therapy isotope business assets into Ionetix-α. POINT will invest $10 million into Ionetix-α.
Upcoming Investor Conferences
Management will participate in the following upcoming investor conferences:
Guggenheim Second Annual Healthcare Talks: Radiopharmaceuticals Day
Format: Fireside Chat and 1×1 Meetings
Date: Monday, May 15, 2023
First Quarter 2023 Financial Results
Cash, Cash Equivalents, and Investments: As of March 31, 2023, POINT had approximately $519.2 million in cash, cash equivalents, and investments, which is anticipated to fund operations into 2026.
Net Loss: Net loss was $16.5 million, or $0.16 net loss per share, for the three months ended March 31, 2023, as compared to a net loss of $16.4 million, or $0.18 net loss per share, for the same period in 2022.
Research and Development Expenses: Research and development expenses were $26.9 million for the three months ended March 31, 2023, as compared to $12.5 million for the same period in 2022.
General and Administrative Expenses: General and administrative expenses were $5.0 million for the three months ended March 31, 2023, as compared to $3.8 million for the same period in 2022.