Lantheus to Present Additional Clinical Data from Phase 3 Pivotal SPLASH Trial in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer During ESMO Congress 2024

Rhea-AI Summary

Lantheus Holdings (NASDAQ: LNTH) announced that additional clinical data from the Phase 3 Pivotal SPLASH Trial for PNT2002 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) will be presented at the ESMO Congress 2024. The presentation, titled 'Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH)', will be delivered by Dr. Oliver Sartor from the Mayo Clinic on September 15, 2024. This presentation will include new data from the initial December 2023 readout, potentially providing important insights into the efficacy of PNT2002 for treating advanced prostate cancer.

Positive

• Presentation of additional clinical data from Phase 3 Pivotal SPLASH Trial at ESMO Congress 2024
• Potential for new insights into PNT2002's efficacy for treating advanced prostate cancer

Negative

• None.

BEDFORD, Mass., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota, will deliver an oral presentation, including additional clinical data from PNT2002’s initial December 2023 readout, during the European Society of Medical Oncology (ESMO) Annual Meeting in Barcelona on Sunday, September 15, 2024.

Title: Efficacy of ¹⁷⁷Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH)

Presentation Number: LBA65

Lecture Date and Time: Sunday, September 15, 2024, 14:45 (CEST), 8:45 a.m. (EDT)

Room: Valencia Auditorium – Hall 5

Presenter: Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota

About ¹⁷⁷Lu-PNT2002
¹⁷⁷Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy candidate that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added lutetium-177. Lantheus in-licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to ¹⁷⁷Lu-PNT2002 from POINT Biopharma (a Lilly company) in December of 2022. In April of 2023, the FDA granted Fast Track designation for ¹⁷⁷Lu-PNT2002 for the treatment of mCRPC. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address unmet medical needs.

About Lantheus
Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in Canada and Sweden, Lantheus has been providing radiopharmaceutical solutions for more than 65 years. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” that are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, statements relating to the potential of PNT2002 and statements regarding Lantheus’ expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Forward-looking statements may be identified by their use of terms such as "development,” “expedited,” “will,” 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. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) the outcome of the SPLASH trial after full data is available; (ii) a delay in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and regulatory authorities for PNT2002; (iii) the additional costs and risks associated with Lantheus’ ability to successfully launch PNT2002 as a commercial product; (iv) the market and patient receptivity to PNT2002 as a radiopharmaceutical therapy; (v) the existence, availability and profile of competing products and therapies; (vi) Lantheus’ ability to obtain and maintain adequate coding, coverage and payment for PNT2002; (vii) the intellectual property protection of PNT2002; (viii) POINT’s ability to successfully develop and scale the manufacturing capabilities to support the launch of PNT2002; and (ix) the risks and uncertainties discussed in Lantheus’ filings with the Securities and Exchange Commission (including those described in the Risk Factors section in its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q). 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. Lantheus 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.

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Senior Director, External Communications
646-975-2533
media@lantheus.com

FAQ

What is the SPLASH trial investigating for Lantheus Holdings (LNTH)?

The SPLASH trial is investigating the efficacy of 177Lu-PNT2002 in PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed on an androgen-receptor pathway inhibitor (ARPI).

When and where will Lantheus (LNTH) present the SPLASH trial data?

Lantheus will present additional clinical data from the SPLASH trial at the European Society of Medical Oncology (ESMO) Annual Meeting in Barcelona on September 15, 2024.

Who will be presenting the SPLASH trial data for Lantheus (LNTH)?

Dr. Oliver Sartor, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota, will deliver the oral presentation on the SPLASH trial data.

What is the significance of the SPLASH trial data presentation for Lantheus (LNTH)?

The presentation will include additional clinical data from PNT2002's initial December 2023 readout, potentially providing important insights into the efficacy of PNT2002 for treating advanced prostate cancer.