On March 25, 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 fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Point Biopharma, MAR 25, 2022, View Source [SID1234610998]).
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"2021 was a transformational year for POINT." said Dr. Joe McCann, CEO of POINT Biopharma. "On January 1st 2021, our company looked like many of its peers. Today, just over a year later, we are one of the only therapeutic radiopharmaceutical companies in the world manufacturing our own radioligands in our own manufacturing facility for our own Phase 3 trial. I am confident this level of successful execution is a direct function of having one of the most experienced teams in the radiopharmaceutical business."
"I am incredibly excited for 2022." Dr. McCann continued. "The advancement of our pan-cancer FAP targeting program PNT2004 into the clinic is the first step in our journey to introduce radiopharmaceuticals in a variety of cancer indications with high unmet need. We also plan to initiate IND enabling studies for PNT2001 this year. PNT2001 is our next-generation PSMA-targeted radioligand which is being developed for delivery of the alpha emitter 225Ac to prostate cancer cells. These are only two of the many exciting milestones we have planned for this year. I look forward to providing updates on our execution throughout this year, as we usher in the next generation of precision oncology medicines to patients." concluded Dr. McCann.
Recent Developments and Upcoming Milestones
Pipeline Updates
PNT2002: 177Lu-based PSMA-targeted radiopharmaceutical
In February 2022, POINT published dosimetry data from the safety and dosimetry lead-in cohort for the Company’s Phase 3 SPLASH trial evaluating PNT2002 for the treatment of mCRPC at the 2022 SNMMI Mid-Winter & ACNM Annual Meeting.
Data from the abstract titled "Dosimetry Results from the SPLASH Trial" (Abstract #: MWMA2244) demonstrated the following:
• Organs receiving the largest absorbed doses were the lacrimal glands at 1.2 Gy/GBq, followed by the kidneys at 0.73 Gy/GBq.
• The average dose to the salivary glands and red marrow was 0.34 Gy/GBq and 0.034 Gy/GBq, respectively.
• For a cumulative administered activity of 27.2 GBq, i.e. four cycles of 6.8 GBq, the kidneys would receive a cumulative absorbed dose of 19.9 Gy, and the red marrow, 0.91 Gy.
• SPECT/CT vs planar-based kidney dosimetry was consistent across most subjects (±20%) where SPECT/CT images were available with a mean kidney absorbed dose difference of 1%.
The Company is currently enrolling patients across 32 sites in North America and Europe. 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) inhibitor
POINT accelerated PNT2004’s therapeutic program after the compelling preclinical data for PNT2004’s lead candidate PNT6555 was first announced in the fourth quarter of 2021. The Company recently completed a pre-CTA meeting in December 2021 with Health Canada regarding the development pathway and clinical study design for the upcoming Phase 1 trial and expects to file a CTA with Health Canada at the end of the first quarter of 2022.
The clinical trial for PNT2004 is expected to commence in summer 2022 in Canada and will use a 68Ga-based PNT6555 molecular imaging agent to select patients to receive a n.c.a. 177Lu-based PNT6555 therapeutic agent. Additional preclinical studies in syngeneic and PDX models for monotherapy and combination treatment are in development and include other therapeutic isotopes such as 225Ac.
PNT2003: n.c.a. 177Lu-labelled somatostatin-targeted radiopharmaceutical
PNT2003’s use of n.c.a. 177Lu enables it to be administered in outpatient clinics without the need for the clinic to maintain costly dedicated waste streams, providing a unique advantage over the currently approved radiopharmaceutical product for the GEP-NETs indication.
The Company is assessing two distinct pathways for PNT2003 with regulatory authorities. These pathways include a 505(b)(2) with the FDA’s Division of Oncology Products and an ANDA with the FDA’s Office of Generic Drugs. The Company is currently waiting to complete discussions with the FDA prior to making a public announcement regarding the pathway which will be pursued. The sponsor of PNT2003 clinical trial has informed the Company that all patients will have completed the primary follow-up in the second quarter of 2022 and will have data to report to the Company in the second half of 2022.
PNT2001: 225Ac-labelled next-generation PSMA-targeted radiopharmaceutical
PNT2001 program leverages linker technology that promotes increased tumor accumulation. Preclinical studies of PNT2001 have resulted in the identification of a lead candidate which, as compared to late-stage PSMA ligands, demonstrates potent anti-tumor activity using 225Ac, while also having an improved biodistribution profile. The company is planning to advance the lead candidate into IND-enabling studies which are expected to support an IND/CTA submission in the first half of 2023. The clinical development pathway being considered for PNT2001 is in recurrent hormone-sensitive prostate cancer as well as in post-Lu-PSMA prostate cancer.
CanSEEKTM: Tumor Microenvironment Targeting Technology
The goal of the CanSEEKTM program is to significantly improve the precision and safety of radioligands. Based on the (d)-Ala-Pro FAP-alpha substrate technology, CanSEEKTM prevents a radioligand from binding to receptors until it has been activated by FAP-alpha in the TME. If successful, CanSEEKTM could significantly improve the therapeutic index of targeted radiopharmaceuticals. Multiple (d)-Ala-Pro substrate enabled ligands are being studied preclinically against different targets.
POINT’s CanSEEKTM has been sub-licensed from both Bach Biosciences and Avacta, who have branded the technology as pre|CISIONTM (an Avacta trademark).
Manufacturing & Supply Chain Updates:
POINT’s Indianapolis manufacturing facility opened in October 2021, the Investigational New Drug (IND) amendment to add the facility to the Company’s supply chain for the SPLASH trial occurred in December 2021, and production of n.c.a. 177Lu PNT2002 clinical trial product commenced 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 October 2021, the Company announced a long-term supply agreement for 176Yb with Kinectrics Inc., a leading service provider to the nuclear power and electricity industry, to support POINT’s in-house n.c.a. 177Lu production program.
Additionally, in October 2021, the Company also announced that it had entered a tri-party co-operation with fellow industry leaders, ARTMS Inc. (ARTMS), and the Canadian Molecular Imaging Probe Consortium (CanProbe), a joint venture between the Centre for Probe Development and Commercialization (CPDC) and the University Health Network (UHN), for the development and clinical use of innovative radiopharmaceuticals in Canada.
In November 2021, the Company announced a technology license agreement for 177Lu purification technology to accelerate POINT’s in-house n.c.a. 177Lu production program with the Belgian Nuclear Research Center ("SCK CEN"). This agreement further reinforces POINT’s supply chain as well as lowers POINT’s cost of medical isotopes.
In November 2021, the Company also announced a long-term supply agreement with IONETIX Corporation, a leading cyclotron technology and isotope manufacturing company for 225Ac to support POINT’s validation, drug development, and clinical trials for 225Ac-based radiopharmaceuticals.
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.
Management Team Updates:
The Company expanded and strengthened its executive leadership team to support its long-term growth.
In December 2021, the Company announced the promotions of Justyna Kelly to Chief Operating Officer (from Vice President, Medical Isotope Development and Operations), Dr. Robin Hallett, Ph.D. to Vice President, Discovery and Translational Sciences (from Senior Director, Preclinical Development), and the election of Jonathan Ross Goodman as Lead Independent Director by the Board of Directors.
Additionally in December 2021, Dr. Sherin Al-Safadi, Ph.D. joined the Company in the role of Vice President, Medical Affairs who was previously Global Medical Affairs Oncology Strategy Director at Bayer, where she developed and executed the medical strategy for the prostate cancer franchise, including the radiopharmaceutical Xofigo.
In January 2022, Dr. Matthew Vincent, Ph.D., J.D., joined the company as Senior Vice President, Business Development. Dr. Vincent brings more than 25 years of pharma business development experience through a variety of partnering, licensing, and M&A transactions and will lead licensing activities for POINT, with a focus on expansion into the Asian markets and strategic partnerships to fully realize the potential of POINT’s pan-cancer targeting technologies.
Corporate Updates:
In December 2021, POINT hosted a virtual education event titled "The First Principles of Radiopharmaceuticals" featuring a presentation and an interactive Q&A session from the Company’s executive leadership team including, Dr. Joe McCann, Chief Executive Officer, Dr. Neil Fleshner, Chief Medical Officer, and Dr. Robin Hallett, Vice President, Discovery and Translational Sciences. A replay of the event is accessible at View Source
Fourth Quarter and Full Year 2021 Financial Results:
Cash and Cash Equivalents: As of December 31, 2021, POINT had approximately $238.8 million in cash and cash equivalents, which is anticipated to fund operations into the first quarter of 2024.
Net Loss: Net loss was $14.2 million, or $0.16 net loss per share, for the quarter ended December 31, 2021, as compared to a net loss of $5.6 million, or $0.10 net loss per share, for the same period in 2020. Net loss was $45.9 million, or $0.62 net loss per share, for the year ended December 31, 2021, as compared to a net loss of $13.4 million, or $0.34 net loss per share, for the same period in 2020.
Research and Development Expenses: Research and development expenses were $9.5 million for the quarter ended December 31, 2021, as compared to $4.1 million for the same period in 2020. Research and development expenses were $33.5 million for the year ended December 31, 2021, as compared to $9.1 million for the same period in 2020.
General and Administrative Expenses: General and administrative expenses were $4.6 million for the quarter ended December 31, 2021, as compared to $1.3 million for the same period in 2020. General and administrative expenses were $12.0 million for the year ended December 31, 2021, as compared to $4.0 million for the same period in 2020.