POINT’s manufacturing facility initiated supply for the Phase 3 SPLASH trial. Randomization of patients for the SPLASH trial expanded to the European Union as scheduled.
CTA filed with Health Canada for Phase 1 therapeutic trial for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program. Trial is expected to commence this summer.
INDIANAPOLIS, May 13, 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 financial results for the first quarter ended March 31, 2022 and provided a business update.
“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
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: https://www.pointbiopharma.com/investors#investor-presentations.
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 https://hub.pointbiopharma.com/dosimetry.
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 https://manufacturing.pointbiopharma.com/.
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.
About POINT Biopharma
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 225Ac and 177Lu. 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/.
About the SPLASH Trial
The Phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in patients with PSMA-expressing mCRPC who have progressed on Androgen receptor-axis-targeted therapies (ARAT) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 patients across North America, Europe and the United Kingdom. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. Patients in arm B who experience centrally assessed radiographic progression and meet protocol eligibility will have the option to crossover and receive PNT2002. Patients will be subject to follow-up for up to 5 years from first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK). POINT anticipates meeting with regulatory agencies in North America, United Kingdom and Europe to gain alignment on requirements for planned submissions after data readout from the SPLASH trial.
Additional information on the Phase 3 SPLASH trial 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 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 the ability to maintain the listing of our 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 our Annual Report on Form 10-K filed with the SEC on March 25, 2022. 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.
Chief of Staff
Investor Relations Contact:
Associate Director, Corporate Strategy
Unaudited Interim Condensed Consolidated Statements of Operations
(In U.S. dollars)
|For the Quarter Ended
|(In U.S. dollars)||2022||2021|
|Research and development||12,500,848||4,269,298|
|General and administrative||3,807,942||1,464,692|
|Total operating expenses||16,308,790||5,733,990|
|Loss from operations||(16,308,790||)||(5,733,990||)|
|Other income (expenses):|
|Finance income (costs)||47,973||(2,799||)|
|Foreign currency loss||(31,641||)||(7,207||)|
|Total other income (expenses)||16,332||(10,006||)|
|Loss before provision for income taxes||(16,292,458||)||(5,743,996||)|
|Provision for income taxes||(88,116||)||(40,425||)|
|Net loss per basic and diluted common share:|
|Basic and diluted net loss per common share||$||(0.18||)||$||(0.10||)|
|Basic and diluted weighted average common shares outstanding||90,122,269||56,673,734|
Interim Condensed Consolidated Balance Sheets
(In U.S. dollars)
|Cash and cash equivalents||227,385,398||238,815,991|
|Prepaid expenses and other current assets||5,228,394||5,030,565|
|Total current assets||232,613,792||243,846,556|
|Property, plant and equipment, net||20,368,465||19,412,086|
|LIABILITIES & STOCKHOLDERS’ EQUITY|
|Income taxes payable||328,903||250,978|
|Total current liabilities||13,642,761||7,979,964|
|Deferred tax liability||65,592||65,592|
|Commitments and contingencies|
|Common Stock, par value $0.0001 per share, 430,000,000 authorized, 90,122,472 and 90,121,794 issued and outstanding as of March 31, 2022 and December 31, 2021, respectively||9,012||9,012|
|Additional paid-in capital||314,930,174||314,488,782|
|Total stockholders’ equity||239,273,904||255,213,086|
|Total liabilities and stockholders’ equity||252,982,257||263,258,642|