POINT Biopharma Reports First Quarter 2023 Financial Results and Provides Business Highlights

U.S. FDA granted Fast Track designation for 177Lu-PNT2002 for the treatment of mCRPC in April 2023

Announces $10 million strategic investment in commercial-scale alpha-emitting isotope manufacturer, Ionetix Alpha Corp.

INDIANAPOLIS, May 15, 2023 (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 financial results for the first quarter ended March 31, 2023 and provided a business update.

“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 1x1 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.

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 aims to transform precision medicine by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, the phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment. Learn more about POINT Biopharma Global Inc. at https://www.pointbiopharma.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 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, our ability to grow and manage our growth profitably and retain our key employees, the impact of COVID-19 on our business, the success, cost and timing of our product development activities and clinical trials, our ability to obtain and maintain regulatory approval for our product candidates, our ability to obtain funding for our operations, our ability to maintain the listing of our common stock on 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 our Annual Report on Form 10-K filed with the SEC on March 27, 2023. Many 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.

Investor Relations Contact:
Daniel Pearlstein
Director, Strategy

Unaudited Interim Condensed Consolidated Statements of Operations
(In U.S. dollars)
  For the Three Months Ended
  March 31,
   2023   2022 
Revenue $9,457,264  $ 
Operating expenses:    
Research and development  26,910,472   12,500,848 
General and administrative  5,010,129   3,807,942 
Total operating expenses  31,920,601   16,308,790 
Loss from operations  (22,463,337)  (16,308,790)
Other income  5,694,024   16,332 
Loss before income taxes  (16,769,313)  (16,292,458)
Income tax benefit (provision)  238,642   (88,116)
Net loss $(16,530,671) $(16,380,574)
Net loss per basic and diluted common share:    
Basic and diluted net loss per common share $(0.16) $(0.18)
Basic and diluted weighted average common shares outstanding  105,660,655   90,122,269 

Interim Condensed Consolidated Balance Sheets
(In U.S. dollars)
 As at March 31, 2023 As at December 31,
 (Unaudited) 2022
Cash, cash equivalents and investments$519,203,535 $541,331,271
Other assets 39,320,674  36,991,465
Total assets$558,524,209 $578,322,736
Liabilities and Shareholder's Equity   
Liabilities$86,744,433 $91,368,943
Shareholder's equity 471,779,776  486,953,793
Total liabilities and shareholder's equity$558,524,209 $578,322,736