225Ac-PSMA-62 / Eli Lilly - LARVOL DELTA

ACCEL: [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | Trial completion date: Mar 2032 ➔ Dec 2032

Trial completion date • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ACCEL: [Ac-225]-PSMA-62 phase Ia/Ib/II clinical trial to characterize efficacy, safety, tolerability, and dosimetry in oligometastatic hormone-sensitive and metastatic castration-resistant prostate cancer. (ASCO-GU 2025) - P1 | "EP-039. Presented at EANM Oct 2022, Barcelona, Spain."

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ACCEL: [Ac-225]-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | N=48 ➔ 142

Enrollment change • Metastases • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

First in human evaluation of PSMA-62: Intraindividual comparison of [Ga-68]-PSMA-62 and [Ga-68]-PMSA-11 PET/CT in patients with mCRPC (SNMMI 2024) - "This pilot study demonstrated that [Ga-68]-PSMA-62 is comparable to [Ga-68]-PSMA-11 in identifying prostate cancer lesions in patients with mCRPC. In addition, [Ga-68]-PSMA-62 has significantly lower salivary gland uptake relative to [Ga-68]-PSMA-11. These preliminary clinical data with [Ga-68]-PSMA-62 are encouraging and suggest that therapy with [Ac-225]-PSMA-62 may lead to reduced incidence and severity of xerostomia relative to currently available PSMA directed radioligands."

Clinical • P1 data • Dental Disorders • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Salivary Gland Cancer • Solid Tumor • Xerostomia

ACCEL: [Ac-225]-PSMA-62 Trial in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

ACCEL: [(A)c-225]-PSMA-62 Phase I/II Clinical Trial to Characterize Efficacy, Safety, ToLerability, and Dosimetry in Biochemically Recurrent and Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: POINT Biopharma

Metastases • New P1 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights (GlobeNewswire) - "Enrollment in PNT2002's phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023....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....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."

New P1 trial • New trial • P1 data • P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Reports Second Quarter 2023 Financial Results and Provides Business Highlights (GlobeNewswire) - "Enrollment in PNT2002's phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023. Six trial sites remain open for recruitment to complete a separate pharmacokinetic sub-study....In May 2023, enrollment in cohort 3 of the phase 1 FRONTIER trial (NCT05432193) began, and a total of seven participants have been dosed with 177Lu-PNT6555 to date. We continue to anticipate data from the full FRONTIER study to be available in the first half of 2024....PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy...We anticipate a health authority submission in the fourth quarter of 2023, and expect the first patient dosed in this trial to be in the first quarter of 2024."

P1 data • P3 data: top line • Regulatory • Trial status • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Cancer • Sarcoma • Skin Cancer • Soft Tissue Sarcoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

POINT Biopharma Reports First Quarter 2023 Financial Results and Provides Business Highlights (GlobeNewswire) - "PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy: PNT2001 builds on POINT’s first-generation, lutetium-based program with a next-generation ligand optimized for use with the alpha-emitting radioisotope actinium-225. We now anticipate a health authority submission for the program lead candidate 225Ac-PSMA-62 in Q4 2023, with the first patient expected for a phase 1 clinical trial in Q1 2024."

New P1 trial • Oncology

Eckert & Ziegler to Supply POINT Biopharma with Actinium-225 (GlobeNewswire) - "Eckert & Ziegler...and a subsidiary of POINT Biopharma Global Inc...have signed an agreement on the supply of Actinium-225 (non-carrier-added Ac-225). Eckert & Ziegler will provide predetermined amounts of GMP grade Ac-225 to POINT for use in the development of POINT’s pipeline of next generation Ac-225-based radioligands....'This agreement with Eckert & Ziegler contributes to our continued research and development with Actinium-225, an exciting therapeutic isotope. We are looking forward to launching our first Ac-225 phase 1 trial for the next generation PSMA-targeted PNT2001 program later this year.' Besides Actinium-225, Eckert & Ziegler also supplies international pharmaceutical companies with Lutetium-177, Gallium-68, Yttrium-90 and other radioisotopes that are essential for use in diagnostics and therapy."

Licensing / partnership • New P1 trial • Oncology

Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003 (GlobeNewswire) - "'We are excited to continue developing and scaling our manufacturing capabilities to support the PNT2002 and PNT2003 launches and continue development of PNT2004, our pan-cancer FAP-α program, which is currently in Phase 1, and PNT2001, our actinium-225 next-generation PSMA program which is expected to begin Phase 1 in 2023'."

Launch • New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Publishes Preclinical Data for Actinium-Labelled PNT2001, a Next-Generation PSMA Ligand, at EANM’s Annual Congress (GlobeNewswire) - "POINT Biopharma...announced the publication of promising new pre-clinical data from the Company’s next-generation radioligand therapy (RLT) program for prostate cancer, PNT2001....In pre-clinical models, 225Ac-PNT2001 demonstrated: Increased internalization by tumor cells in vitro, compared to that of a first-generation ligand; More precise tumor targeting in vivo (due to decreased kidney uptake, high tumor retention, and rapid renal clearance), leading to a promising safety profile in murine models....POINT aims to accelerate radiochemistry and formulation optimization, as well as cGMP process and method development and validation, to facilitate progression to an IND/CTA submission in H1 2023."

IND • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Provides Early-Stage Program Updates (GlobeNewswire) - "The Company has advanced the lead candidate into IND-enabling studies which are expected to support an IND/CTA submission in H1 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."

IND • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

POINT Biopharma Reports Third Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - "PNT2002: Investigational 177Lu-PSMA targeted radioligand therapy...Enrollment for this phase of the SPLASH study has commenced in Canada and will continue to expand globally in the fourth quarter of 2021; POINT is progressing through IND enabling studies and clinical development plans with expectations to submit an IND/CTA for PNT2004 in the first half of 2022; PNT2001: Family of next-generation PSMA radioligands...The Company plans to advance a single compound from the family for the treatment of prostate cancer and expects to initiate IND-enabling studies for the program in 2022; Research and development expenses were $13.0 million for the quarter ended September 30, 2021, as compared to $2.5 million for the same period in 2020."

Commercial • Enrollment status • IND • New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma and IONETIX Announce Ac-225 Supply Agreement (GlobeNewswire) - "POINT Biopharma Global Inc...and IONETIX Corporation...announced today a long-term supply agreement for actinium-225 (Ac-225) to support POINT’s validation, drug development, and clinical trials for Ac-225-based radiopharmaceuticals....POINT plans to use Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) directed radioligand for non-metastatic castrate-sensitive prostate cancer (nmCSPC) and PNT2004, a Fibroblast Activation Protein-α inhibitor candidate with potential pan-cancer applications."

Clinical • Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer

NorthStar Medical Radioisotopes and POINT Biopharma Announce Supply Agreement for Therapeutic Medical Radioisotope Actinium-225 (Businesswire) - "NorthStar Medical Radioisotopes, LLC...and POINT Biopharma Global Inc...announced the signing of a supply agreement for the therapeutic medical radioisotope actinium-225....Under the terms of the agreement, NorthStar will provide POINT with its electron accelerator-produced Ac-225 and POINT will use NorthStar’s Ac-225 in investigational studies of PNT2001, a next-generation Prostate-Specific Membrane Antigen (PSMA) for non-metastatic castrate-sensitive prostate cancer (nmCSPC); PNT2004, a Fibroblast Activation Protein-α candidate with potential pan-cancer applications; and to advance its novel Tumor Microenvironment (TME) tumor-targeting technology platform."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

POINT Biopharma Reports Second Quarter 2021 Financial Results and Provides Business Update (GlobeNewswire) - “PNT2002…The Company expects to report top-line data from the SPLASH study in mid-2023…PNT2003…The Company expects to report data from this study in the first half of 2022…PNT2001…The Company expects to advance a single compound from the family and initiate IND-enabling studies for this program in 2022.”

IND • P3 data • P3 data: top line • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Solid Tumor