ADDED
As of February 23, 2026 the registrant had 64,605,894 shares of common stock, $0.01 par value, issued and outstanding.
Examples of forward-looking statements include statements we make relating to our outlook and expectations including, without limitation, in connection with: Continued market expansion, penetration and reimbursement for our established commercial products, particularly PYLARIFY, DEFINITY and Neuraceq, in a competitive environment, and our ability to clinically and commercially differentiate our products; Our ability to obtain U.S.
SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS Our business is subject to a number of risks, including risks that may adversely affect our business, results of operations, cash flows, and prospects.
Risks Related to Our Business Operations and Financial Results Changes to management, including the recent turnover in our leadership and senior management team, could have an adverse effect on our business.
Our ability to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business.
Our use of artificial intelligence or other emerging technologies could adversely affect our business, results of operations, financial condition and cash flows.
Risks associated with the commercialization of LNTH-2501, including (A) our ability to obtain regulatory approval for LNTH-2501; (B) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for LNTH-2501; and (C) our manufacturer s ability to successfully develop and scale the manufacturing capabilities to support the launch of LNTH-2501.
and Advanced Accelerator Applications SA, each a Novartis entity, in response to our filing of our Abbreviated New Drug Application; (B) our ability to obtain regulatory approval for PNT2003; (C) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for PNT2003; and (D) POINT Biopharma Global Inc.
s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2003.
Risks associated with our agreements with Perspective Therapeutics, Inc.
REMOVED
As of February 20, 2025 the registrant had 68,476,575 shares of common stock, $0.01 par value, issued and outstanding.
Food and Drug Administration ( FDA ) approval for PNT2002 and PNT2003 and to be successful in the patent litigation associated with PNT2003; Our ability to successfully realize the anticipated benefits of our 2024 transactions with Perspective Therapeutics, Inc.
( Perspective ); The cost, efforts and timing for clinical development, regulatory approval, adequate coding, coverage and payment, and successful commercialization of our product candidates and new clinical applications and territories for our products, in each case, that we or our strategic partners may undertake; and Our ability to identify opportunities to collaborate with strategic partners and to acquire or in-license additional diagnostic and therapeutic product opportunities in oncology, neurology and other strategic areas and continue to grow and advance our pipeline of products.
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part I, Item 1A, "Risk Factors" of this Form 10-K.
Risks Related to our Business Operations and Financial Results Our ability to hire or retain the number of qualified personnel, particularly scientific, medical and sales personnel, required for our business.
Our ability to continue to grow PYLARIFY and to successfully launch new PET diagnostic products, including MK-6240 and NAV-4694, is dependent upon the availability of PET scanners generally.
( Endocyte ), Novartis and Purdue Research Foundation against POINT and Eli Lilly and Co ( Lilly ) alleging that POINT s manufacturing and sale of PNT2002 infringes an Endocyte patent.
and Advanced Accelerator Applications SA, each a Novartis entity, in response to our filing of our Abbreviated New Drug Application; (B) our ability to obtain regulatory approval for PNT2003, including the 180-day period of generic marketing exclusivity in the U.S.
market as the first applicant, as provided under the Hatch-Waxman Act; (C) our ability to gain post-approval market acceptance and adequate coding, coverage, and payment for PNT2003; and (D) POINT s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2003.
Business Overview We are the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes.