8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) June 25, 2018
 

Progenics Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware	000-23143	13-3379479
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)
One World Trade Center, New York, New York (Address of principal executive offices)		10007 (Zip Code)
Registrant's telephone number, including area code		(646) 975-2500

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On June 25, 2018, Progenics Pharmaceuticals, Inc. (“Progenics” or the “Company”) issued a press release announcing that it presented data demonstrating the utility of its imaging analysis technology, which uses artificial intelligence and machine learning to quantify and automate the reading of PSMA targeted imaging, in an oral presentation at the 2018 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting on June 23, 2018 in Philadelphia, Pennsylvania. On June 26, 2018, Progenics issued a press release announcing the completion of patient enrollment in the Company’s Phase 2/3 OSPREY clinical trial evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL^TM (18F-DCFPyL), in prostate cancer. A copy of each of the foregoing press releases is furnished as, respectively, Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and each is incorporated in this Item 7.01 by reference.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.1	Press Release announcing Progenics’ presentation at the 2018 SNMMI Annual Meeting, dated June 25, 2018
99.2	Press Release announcing completion of enrollment in the Phase 2/3 OSPREY clinical trial, dated June 26, 2018

SIGNATURES 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

PROGENICS PHARMACEUTICALS, INC.

By: /s/ Patrick Fabbio

 Patrick Fabbio

 Senior Vice President and Chief Financial Officer

 (Principal Financial and Accounting Officer)

Date: June 26, 2018

EX-99.1

Exhibit 99.1

Progenics Pharmaceuticals Presents Data Validating its Artificial Intelligence Imaging Analysis Technology for Use with PSMA-Targeted SPECT/CT

-Algorithm Validated Using Data from Company’s 1404 Phase 2 Study-

New York, N.Y., June 25, 2018 – Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging technology for targeting and treating cancer, reported data demonstrating the utility of its imaging analysis technology, which uses artificial intelligence and machine learning to quantify and automate the reading of PSMA targeted imaging. The data were presented in an oral presentation at the 2018 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting on June 23^rd in Philadelphia, Pennsylvania.

In the presentation, titled “Automated Detection and Quantification of Prostatic PSMA Uptake in SPECT/CT using a Deep Learning Model for Segmentation of Pelvic Anatomy,” researchers described the validation of a deep learning algorithm for the automatic detection and quantification of 1404 uptake from SPECT/CT images. 1404 is Progenics’ PSMA-targeted SPECT/CT imaging agent, currently in Phase 3 development.

“This study successfully validates Progenics’ imaging analysis technology platform for use with PSMA-targeted SPECT/CT, and shows the promise of using artificial intelligence to automate the reading and interpretation of prostate cancer scans,” stated Lars Edenbrandt, MD, PhD, Professor and Senior Specialist, Department of Molecular and Clinical Medicine, University of Gothenburg, “PSMA-targeted imaging, together with sophisticated algorithms and machine learning, have the potential to significantly improve how clinicians stage prostate cancer, monitor disease progression and manage treatment, which could potentially lead to better patient outcomes.”

“Progenics is leading the way in applying the use of artificial intelligence and machine learning to improve how we find, fight and follow prostate cancer,” stated Mark Baker, Chief Executive Officer of Progenics. “We have previously shown how our artificial intelligence-based imaging analysis technology can have clinical utility as a prognostic tool for bone scan images in metastatic prostate cancer. This study builds on that evidence and illustrates how our AI technology can be applied across imaging modalities, such as SPECT/CT. We look forward to advancing the development of this platform, together with our novel, PSMA-targeted imaging agents, to potentially transform the prostate cancer treatment management.”

The algorithm developed by Progenics’ imaging analysis technology was validated using the data from the Company’s Phase 2 study of 1404, which included 102 high-risk prostate cancer patients who all underwent PSMA imaging prior to radical prostatectomy. The validation scans were manually quantified by measuring the maximum uptake of 1404 in a circular region of interest of the prostate where the highest uptake values were determined visually. The algorithm used volumetric segmentation to measure uptake at every voxel in the prostate and determined the maximum uptake of 1404 automatically. The Pearson correlation coefficient was used to assess the concordance between manual and automated quantification of uptake. The automated maximum uptake value was significantly correlated to the manually obtained uptake value (p<0.0001). The algorithm was fully automated and deterministic, resulting in 100% repeatability.

About Progenics

Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis technology. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.

This press release contains projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs, including our NDA for AZEDRA; market acceptance for approved products; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission, including those risk factors included in its Annual Report on Form 10-K for the annual period ended December 31, 2017. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.

Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company's SEC filings.

(PGNX-F)

Contact: Melissa Downs   Investor Relations   (646) 975-2533   mdowns@progenics.com

EX-99.2

Exhibit 99.2

 

Progenics Pharmaceuticals Completes Enrollment of Phase 2/3 Clinical Trial of PSMA-Targeted PET/CT Imaging Agent PyL™ in Prostate Cancer

Top-line Data Expected in 4Q2018

New York, N.Y., June 26, 2018 – Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and imaging technology for targeting and treating cancer, today announced that it has completed enrollment in its Phase 2/3 OSPREY clinical trial evaluating the diagnostic accuracy of its PSMA-targeted PET/CT imaging agent, PyL^TM (18F-DCFPyL), in prostate cancer.

"The completion of enrollment for our PyL trial, ahead of schedule, marks an important milestone for the advancement of our PSMA-targeted pipeline," said Mark Baker, Chief Executive Officer of Progenics. “PyL is a PSMA-targeted PET imaging agent that has the potential to transform how physicians manage and treat prostate cancer from time of initial diagnosis to metastatic or recurrent disease; it has the potential to detect very small bone and soft tissue metastases at earlier stages in the disease progression. We look forward to reporting top-line data from the trial in the fourth quarter of 2018 while initiating a second Phase 3 study of PyL in patients with biochemical recurrence of prostate cancer by year end.”

The OSPREY study enrolled 266 patients with localized high risk prostate cancer and 117 patients with recurrent or metastatic disease in the United States and Canada for a total of 383 patients. The study’s co-primary endpoints include the assessment of sensitivity and specificity of PyL PET/CT imaging to detect prostate cancer in regional lymph nodes in patients scheduled to undergo radical prostatectomy. Secondary endpoints include sensitivity within sites of metastasis or recurrence, and other diagnostic performance characteristics, pharmacokinetic parameters, and safety and tolerability.

About PyL^TM for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a fluorinated PSMA-targeted Positron Emission Topography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

About Progenics

Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA^®, 1095, and PSMA TTC), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis technology. Progenics' first commercial product, RELISTOR^® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with Valeant Pharmaceuticals International, Inc.

This press release contains projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs, including our NDA for AZEDRA; market acceptance for approved products; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission, including those risk factors included in its Annual Report on Form 10-K for the annual period ended December 31, 2017. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.

Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company's SEC filings.

(PGNX-F)

Contact: Melissa Downs   Investor Relations   (646) 975-2533   mdowns@progenics.com