This website contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “believe,” "continue,” “could,” “creates,” "expected,” “expects,” “looks,” “may,” “plans,” “positioned,” “potential,” “will,” “would” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the timing and potential outcomes of clinical studies, including POINT’s Phase 3 SPLASH trial for PNT2002 and the OZM-067 study for PNT2003; (ii) the timing and outcome of Hart-Scott-Rodino antitrust clearance; (iii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002 and PNT2003; (iv) Lantheus’ ability to successfully launch PNT2002 or PNT2003 as commercial products; (v) the market receptivity to PNT2002 or PNT2003 as radiopharmaceutical therapies; (vi) the existence, availability and profile of competing products and therapies; (vii) our ability to obtain and maintain adequate coding, coverage and payment for PNT2002 and PNT2003; (viii) the safety and efficacy of PNT2002 and PNT2003; (ix) the intellectual property protection of PNT2002 and PNT2003; (x) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002 and PNT2003; and (xi) the risks and uncertainties discussed in Lantheus’ and POINT’s filings with the Securities and Exchange Commission (including those described in the Risk Factors section in their Annual Reports on Form 10-K and their Quarterly Reports on Form 10-Q).I Acknowledge
PNT2002 is a PSMA-targeted 177Lu-based radiopharmaceutical therapy for metastatic castration-resistant prostate cancer (mCRPC) and combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu. Every year in the United States 70,000 men are eligible for treatment for mCRPC*. PNT2002 is currently in its Phase 3 study designed to evaluate superiority to the standard of care in mCRPC pre-chemotherapy patients who have failed one androgen receptor pathway inhibitor.
*DRG / Clarivate Prostate Cancer Disease Landscape and Forecast 2022
PNT2003 is a somatostatin receptor (SSTR) targeted radioligand therapy with no-carrier-added 177Lu, in development for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). SSTRs are seen as ideal targets for NET therapy and somatostatin analogs (SSAs) have been developed with anti-secretory and anti-proliferative effects for NET therapy, and randomized clinical trials with somatostatin analogs have demonstrated efficacy. PNT2003 is currently in a Phase 3 trial.
With more than 65 years of experience in delivering life-changing science, Lantheus is committed to improving patient outcomes through diagnostics, radiotherapeutics and artificial intelligence solutions that enable clinicians to Find, Fight and Follow disease. Lantheus provides a broad portfolio of products, including PYLARIFY® (Piflufolastat F18), a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer and AZEDRA® (Iobenguane I 131) for the treatment of certain rare neuroendocrine tumors.
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Stock Symbol: LNTH (NASDAQ)
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Senior Director, Corporate Communications
POINT is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision medicine by combining a portfolio of next generation radiopharmaceutical assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for rare medical isotopes.
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Stock Symbol: PNT (NASDAQ)
Associate Director, Corporate Strategy