Progenics Pharmaceuticals Announces Q1 2017 Financial Results and Business Update

5/4/17

NEW YORK, May 04, 2017 (GLOBE NEWSWIRE) -- Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced financial results and provided a business update for the first quarter of 2017.

“This first quarter of 2017 was marked by major developments within our clinical pipeline, particularly the announcement of positive topline data from our registrational Phase 2b study of AZEDRA for the treatment of pheochromocytoma and paraganglioma,” said Mark Baker, Chief Executive Officer of Progenics. “The study not only achieved its primary endpoint by a significant margin, but also showed that treatment with AZEDRA resulted in favorable anti-tumor activity, a key secondary endpoint. We are now working diligently to complete our New Drug Application for this important new therapy, which we remain on track to submit by the middle of this year.”

Mr. Baker continued, “With our portfolio of PSMA-targeted therapeutics and imaging agents, we continue to leverage our Find Fight and Follow™ strategy that provides us with multiple opportunities to improve the lives of patients who have or are at risk of developing prostate cancer. During the quarter, we continued to advance clinical trials of our three prostate cancer theranostic candidates, 1404, PyL, and 1095, reported positive data regarding our Automated Bone Scan Index (aBSI), and look forward to providing further updates on our progress throughout the year.”

First Quarter and Recent Key Business Highlights

AZEDRA, Ultra-orphan radiotherapeutic candidate

  • Positive Topline Results for AZEDRA Announced in the First Quarter 2017. In March 2017, Progenics reported positive topline data from its Phase 2b registrational trial of AZEDRA for the treatment of rare and difficult-to-treat neuroendocrine tumors, pheochromocytoma and paraganglioma. The primary endpoint evaluated a proportion of patients who achieved a 50% or greater reduction in all antihypertensive medication for at least six months. Under the study protocol agreed to with the U.S. Food and Drug Administration (FDA), the primary endpoint was to be achieved if the lower limit of the two-sided 95% confidence interval was above 10%. In order to achieve this primary endpoint, a minimum of 12 of the total 68 evaluable patients must have a 50% or greater reduction of all antihypertensive medication for at least 6 months.

    The trial met the primary endpoint with 17 of the 68 evaluable patients experiencing at least a 50% reduction in all antihypertensive medication for at least six months, with a 95% confidence interval lower limit of 16.15%. In addition, favorable data was reported for a key secondary endpoint, the proportion of patients with overall tumor response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Of the 64 RECIST evaluable patients, 92.2% of patients showed a best response of partial response or stable disease.

    AZEDRA was generally well tolerated. The most common treatment emergent adverse events were nausea, thrombocytopenia, anemia, fatigue, leukopenia, and neutropenia. These events are consistent with those observed in prior AZEDRA studies.

    Based on these data, the Company has already submitted non-clinical sections of the New Drug Application to the FDA and expects to complete the submission by mid-2017.

PSMA-Targeted Prostate Cancer Pipeline

  • Data Presentations Highlighting Utility of Automated Bone Scan Index (aBSI). In February 2017, data was presented at the American Society of Clinical Oncology Genitourinary (ASCO GU) Meeting demonstrating the utility of Progenics’ aBSI to quantitatively assess total tumor burden during the course of disease progression as called for by the Prostate Cancer Working Group (PCWG). The data will also be presented at the upcoming ASCO 2017 meeting. Also at ASCO, a prognostic analysis of aBSI in men with metastatic castration-resistant prostate cancer (mCRPC) using data from a Phase 3 trial of a prostate cancer therapeutic will be discussed in an oral presentation.
  • Phase 3 Study of 1404 Remains On-Track; Phase 2 Data Published in the Journal of Nuclear Medicine. Progenics continues to enroll patients in a Phase 3 study of 1404. The trial is designed to evaluate the specificity of the imaging agent in identifying patients without clinically significant prostate cancer as well as its sensitivity to identify patients with clinically significant disease, and will include approximately 450 patients. Progenics still expects to complete enrollment by the end of 2017. 
  • In March 2017, data from a Phase 2 study of 1404 were published in the online edition of the Journal of Nuclear Medicine. The data reviewed previously reported results demonstrating the sensitivity of 1404 to detect prostate cancer, potentially enabling better assessment of the stage and extent of a patient’s prostate cancer versus biopsy.
  • Advancing Phase 2/3 Study of PyL™. Progenics’ study evaluating the diagnostic accuracy of PyL PET/CT imaging in patients with metastatic prostate cancer continues to enroll patients. The Phase 2/3 study will enroll approximately 300 patients with recurrent and/or metastatic prostate cancer in the United States and Canada.
  • Initiated Phase 1 Trial of 1095. Dosing has commenced in the Phase 1 open-label dose escalation study of 1095. The study, which is being conducted at Memorial Sloan Kettering, is expected to enroll approximately 30 patients with mCRPC who have demonstrated tumor avidity to 1095. The study’s primary objectives are to determine the maximum tolerated dose, safety and tolerability, biodistribution, and efficacy.

RELISTOR, treatment for opioid-induced constipation (partnered with Valeant Pharmaceuticals International, Inc.)

  • First Quarter 2017 RELISTOR® Net Sales of $14.1 Million. The first quarter 2017 sales, as reported to Progenics by its partner Valeant, translated to $2.1 million in royalty revenue for Progenics for the quarter.

First Quarter 2017 Financial Results

First quarter revenue totaled $2.3 million, down from $2.5 million in the first quarter of 2016, reflecting RELISTOR royalty income of $2.1 million compared to $2.2 million in the corresponding period of 2016.

First quarter research and development expenses increased by $0.9 million compared to the corresponding prior year period, resulting primarily from higher clinical trial and contract manufacturing expenses for PyL, partially offset by lower compensation expenses. First quarter general and administrative expenses decreased by $0.1 million compared to the corresponding prior year period, primarily attributable to lower depreciation and compensation expenses, partially offset by higher costs associated with pre-launch activities for AZEDRA. Progenics also recorded a non-cash charge of $1.9 million in the first quarter related to an increase in the fair value estimate of the contingent consideration liability primarily resulting from an increase in the probability of success of AZEDRA used to calculate the potential milestone payments to former Molecular Insight Pharmaceuticals, Inc. stockholders. For the three months ended March 31, 2017, Progenics recognized interest expense, including amortization of the debt discount, related to the RELISTOR royalty-backed loan, of $1.3 million.

Net loss attributable to Progenics for the quarter was $16.4 million or $0.23 per diluted share, compared to a net loss of $12.7 million or $0.18 per diluted share in the corresponding 2016 period. Progenics ended the quarter with cash and cash equivalents of $126.3 million, a decrease of $12.6 million compared to cash and cash equivalents as of December 31, 2016.

About RELISTOR®

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) are approved in the United States for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for OIC approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.

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