On November 14, 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 third quarter ended September 30, 2022, and provided an update on business highlights, including the announcement of a strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. (NASDAQ: LNTH) for the commercialization of PNT2002 & PNT2003 (Press release, Point Biopharma, NOV 14, 2022, View Source [SID1234624036]).
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Upon consummation of the agreements, in exchange for the exclusive worldwide rights1, Lantheus will pay a total of $260 million in upfront payments between the two agreements to POINT, with the potential for additional milestone payments of approximately $1.8 billion between the two products based on U.S. Food and Drug Administration (FDA) approval and net sales and commercial milestones. Additionally, Lantheus will pay POINT royalties on net sales, beyond certain financial thresholds and subject to conditions, of 20% for PNT2002 and 15% for PNT2003. Additional terms of the agreements are summarized below and a website with more information about the collaboration is accessible at View Source and the Company’s website.
"We are very pleased to have reported the Lantheus strategic collaboration earlier this morning. The terms of the deal affirm for us the value of POINT’s platform and maximizes value for both shareholders and patients," said Joe McCann, Ph.D., CEO of POINT Biopharma. "We founded POINT to accelerate the discovery, development, and global access to life-changing radiopharmaceuticals, and with this collaboration POINT is now better positioned than ever to execute on our mission. With our financial position further strengthened, we can continue to focus on our core competencies and dedicate resources to our pipeline. Specifically, we believe that PNT2004 is an incredibly exciting, high value opportunity. PNT2004 is our pan-cancer FAP-α program, which is currently in Phase 1. We will also continue to invest in PNT2001, our actinium-225 next-generation PSMA program, which is expected to begin Phase 1 in 2023, and other next-generation radioligand opportunities."
Recent Developments and Upcoming Milestones
Pipeline Updates
PNT2002: 177Lu-based PSMA targeted radiopharmaceutical
In September 2022, the Company published a poster at ESMO (Free ESMO Whitepaper) Congress 2022 containing efficacy and safety data from the 27-patient safety and dosimetry lead-in cohort for the Company’s phase 3 SPLASH trial (NCT04647526) evaluating PNT2002 for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The poster was titled "Efficacy and Safety of 177Lu-PNT2002 prostate-specific membrane antigen (PSMA) Therapy in Metastatic Castration Resistant Prostate Cancer (mCRPC): Initial Results from SPLASH" (e-Poster #1400P). Key findings include a median rPFS time of 11.5 months, along with a well-tolerated safety profile with no treatment-related deaths and few treatment-related adverse events of grade 3 or higher.
The SPLASH trial is currently enrolling patients across 55 sites in North America, Europe, and United Kingdom, and recruitment is expected to be completed by the end of the calendar year. The Company continues to expect to report top line data from SPLASH in mid-2023.
PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical
The phase 1 FRONTIER trial (NCT05432193) for the Company’s pan-cancer fibroblast activation protein-α (FAP-α) targeted program, PNT2004, commenced in July 2022. FRONTIER is evaluating PNT6555 (the lead candidate of PNT2004) in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcomas. A gallium-68 (68Ga)-based PNT6555 molecular imaging agent is being used to select patients for the study, those selected then receive a no-carrier-added (n.c.a.) lutetium-177 (177Lu)-based PNT6555 therapeutic agent.
The primary objective of the study is to determine the recommended phase 2 dose (RP2D), as guided by a modified toxicity probability interval-2 design. Phase 1 data from FRONTIER is expected in H1 2024.
PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical
In October 2022, POINT published promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001. The new PNT2001 data were shared in E-poster #039, "Development and characterization of a next-generation 225Ac-PMSA radioligand," at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM) in Barcelona, Spain. The Company is targeting an IND/CTA submission for PNT2001 in H1 2023, with the first patient expected for a phase 1 clinical trial by EOY 2023.
Corporate Updates:
In September 2022, the Company closed a previously announced underwritten public offering of 13,900,000 shares of Common Stock at a public offering price of $9.00 per share. Subsequent to closing, the underwriter exercised its option to purchase an additional 1,589,779 shares. The gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $140 million.
Three Months and Nine Months Ended 2022 Financial Results
Cash, Cash Equivalents and Investments: As of September 30, 2022, POINT had approximately $291.5 million in cash, cash equivalents and investments, which is anticipated to fund operations into the fourth quarter of 2024.
Net Loss: Net loss was $24.0 million, or $0.26 net loss per share, for the three months ended September 30, 2022, as compared to a net loss of $17.1 million, or $0.19 net loss per share, for the same period in 2021. Net loss was $65.0 million, or $0.71 net loss per share, for the nine months ended September 30, 2022, as compared to a net loss of $31.7 million, or $0.46 net loss per share, for the same period in 2021.
Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended September 30, 2022, as compared to $13.0 million for the same period in 2021. Research and development expenses were $54.1 million for the nine months ended September 30, 2022, as compared to $24.0 million for the same period in 2021.
General and Administrative Expenses: General and administrative expenses were $3.8 million for the three months ended September 30, 2022, as compared to $4.0 million for the same period in 2021. General and administrative expenses were $11.7 million for the nine months ended September 30, 2022, as compared to $7.4 million for the same period in 2021.
1. Excluding the following territories: China (inclusive of Taiwan, Hong Kong and Macau), Japan, South Korea, Indonesia and Singapore, which are retained by POINT.
About the SPLASH Trial
The phase 3 SPLASH trial is a multi-center, randomized, open label assessment of PNT2002 in participants with PSMA-expressing mCRPC who have progressed on androgen receptor pathway inhibitor (ARPI) therapy and refuse, or are not eligible for, chemotherapy. The randomization phase of the study is expected to enroll approximately 400 participants across North America, Europe, and the United Kingdom. Participants will be randomized 2:1 with participants in arm A receiving PNT2002 and participants in arm B receiving either abiraterone or enzalutamide. Participants 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 their first PNT2002 dose. The primary endpoint of the study is radiographic progression-free survival. Key secondary endpoints include overall response rate, overall survival, and pharmacokinetics.
About the FRONTIER Trial
The FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability, and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients with Select Solid Tumors (FRONTIER) trial is an open-label, phase 1 trial to evaluate safety, tolerability, and dosimetry of 177Lu-PNT6555 and 68Ga-PNT6555, the lead assets of the PNT2004 program. The phase 1 clinical trial commenced in summer 2022 in Canada and uses a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a no-carrier-added (n.c.a.) 177Lu-based PNT6555 therapeutic agent. The phase 1 clinical protocol will evaluate PNT6555 in approximately 30 patients in five FAP-avid cancer indications: colorectal, pancreatic, esophageal, melanoma, and soft tissue sarcoma.