On November 13, 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 third quarter ended September 30, 2023, and provided a business update (Press release, Point Biopharma, NOV 13, 2023, View Source [SID1234637573]).
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"The founding mission of our company is to accelerate the discovery, development and global access to radiopharmaceuticals," said Joe McCann, Ph.D., CEO of POINT Biopharma. "I view Lilly’s agreement to acquire POINT as validation of the uniqueness of our team, infrastructure and pipeline. Together, we can become a global radiopharmaceutical leader, executing on our mission and transforming lives touched by cancer."
POINT to be Acquired by Lilly
On October 3, 2023, Eli Lilly and Company (NYSE: LLY) and POINT Biopharma Global Inc. (NASDAQ: PNT) announced a definitive agreement for Lilly to acquire POINT for a purchase price of $12.50 per share in cash (an aggregate of approximately $1.4 billion) payable at closing. The purchase price payable at closing represents a premium of approximately 87% to POINT’s closing stock price on Oct. 2, 2023, the last trading day before the announcement of the transaction, and 68% to the 30-day volume-weighted average price. The tender offer, which was previously scheduled to expire at one minute past 11:59 p.m., Eastern time, on Nov. 9, 2023, has been extended until 5:00 p.m., Eastern time, on Nov. 16, 2023, unless the tender offer is further extended or earlier terminated, in order for the parties to satisfy outstanding closing conditions. The proposed acquisition is expected to close near the end of 2023, subject to customary closing conditions, including the tender of at least a majority of the outstanding Shares as of the expiration of the tender offer.
Business Highlights and Upcoming Milestones
Pipeline Updates
PNT2002: 177Lu-labelled PSMA-targeted radioligand therapy
Enrollment in PNT2002’s phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023.
PNT2004: fibroblast activation protein-α (FAP-α) targeted radioligand therapy
The PNT2004 program leverages the D-ala-boroPro FAP targeting warhead, which is a potent and selective FAP inhibitor. PNT6555 is the current clinical lead in the PNT2004 program.
The phase 1 FRONTIER trial (NCT05432193) utilizing 68Ga/177Lu-labelled PNT6555 closed enrollment after the dosing of cohort 3 (12 GBq) in October. There are no plans for expansion of the third cohort, and there were no dose limiting toxicities. Analysis of the dosimetry and clinical data from the FRONTIER trial is underway and includes pancreatic ductal adenocarcinoma, colorectal cancer, cholangiocarcinoma, and esophageal cancer subjects.
Presentation of data from the FRONTIER study is anticipated in the first half of 2024, and based on initial promising data we expect to advance at least one 2nd-generation D-ala-boroPro-based lead into the clinic next year.
PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy
For the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001’s actinium-225 program, we expect the first patient dosed in this trial to be in the first quarter of 2024. The trial was designed to enable the parallel exploration of PNT2001 in two populations: patients with later-stage mCRPC and patients with earlier-stage BCR or PSMA-positive oligorecurrent disease.
Manufacturing & Supply Chain Updates
In July 2023, we announced an expanded agreement with ITM Isotope Technologies Munich SE (ITM), which broadens the supply of ITM’s no-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline.
In September 2023, we signed a supply agreement with Eckert & Ziegler AG for no-carrier-added lutetium-177 (n.c.a. 177Lu).
Discovery Updates
In September 2023, we announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands ("Radio-DARPins"). The collaboration gives POINT exclusive access to Athebio’s intellectual property and capabilities in DARPin development in the radioligand therapy field. Together, the parties will collaborate in discovery, candidate selection and preclinical development of Athebody DARPins for use as Radio-DARPin drug entities. POINT will be solely responsible for the clinical development and commercialization of Radio-DARPins translated from the discovery collaboration.
Third Quarter 2023 Financial Results
Cash, Cash Equivalents, and Investments: As of September 30, 2023, POINT had approximately $399.0 million in cash, cash equivalents, and investments, which is anticipated to fund operations into 2026.
Net Loss: Net loss was $24.8 million and $66.7 million, or $0.23 and $0.63 net loss per share, for the three and nine months ended September 30, 2023, respectively, as compared to a net loss of $24.0 million and $65.0 million, or $0.26 and $0.71 net loss per share, respectively, for the same periods in 2022.
Research and Development Expenses: Research and development expenses were $26.9 million and $85.1 million for the three and nine months ended September 30, 2023, respectively, as compared to $20.8 million and $54.1 million, respectively, for the same periods in 2022.
General and Administrative Expenses: General and administrative expenses were $5.5 million and $15.6 million for the three and nine months ended September 30, 2023, respectively, as compared to $3.8 million and $11.7 million for the same periods in 2022.