On August 4, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2016 (Filing, Q2, Oncolytics Biotech, 2016, AUG 4, 2016, View Source [SID:1234514385]).

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"The key highlights for the quarter were preliminary data from randomized Phase 2 studies in colorectal and non-small cell lung cancer, which together suggested a possible linkage between gender, genetic status and survival outcomes in these common cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our ongoing randomized Phase 2 program continues to provide important data as to indications, patient populations and pre-screening methodologies that we can use to advance our later-stage clinical program."

Selected Highlights

Since April 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), presented following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which correlated both patient gender (female) and genetic status to improved progression free and overall survival;
· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)) and those patients of either gender with liver metastases (those treated with REOLYSIN had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN (p=0.0077));
· Submission to the U.S. Food and Drug Administration of an Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver", which is now active;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research

· A poster presentation covering preclinical work in squamous cell carcinoma of the head and neck being made at the 2016 American Society of Gene and Cell Therapy annual meeting;
· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Corporate

· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and
Financial

· At June 30, 2016 the Company reported $20.4 million in cash, cash equivalents and short-term investments. At August 3, 2016, the Company had approximately $19.5 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies and other clinical studies.

ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)


June 30,
2016
$

December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 18,320,981 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,633 340,059
Prepaid expenses 530,470 506,669
Total current assets 20,994,884 26,923,980

Non-current assets
Property and equipment 372,854 459,818
Total non-current assets 372,854 459,818

Total assets 21,367,738 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,780,705 2,709,492
Total current liabilities 2,780,705 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
June 30, 2016 – 118,900,812
December 31, 2015 – 118,151,622 261,975,522 261,324,692
Contributed surplus 26,438,232 26,277,966
Accumulated other comprehensive loss 460,092 760,978
Accumulated deficit (270,286,813) (263,689,330)
Total shareholders’ equity 18,587,033 24,674,306
Total liabilities and equity 21,367,738 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

Three
Month
Period
Ending
June 30,
2016
$ Three
Month
Period
Ending
June 30,
2015
$ Six Month
Period
Ending
June 30,
2016
$ Six Month
Period
Ending
June 30,
2015
$
Expenses
Research and development 1,490,956 2,471,554 4,217,085 4,897,093
Operating 1,125,458 1,422,055 2,485,870 2,604,789
Operating (loss) (2,616,414) (3,893,609) (6,702,955) (7,501,882)
Interest income 35,537 44,122 105,158 100,557
Loss before income taxes (2,580,877) (3,849,487) (6,597,797) (7,401,325)
Income tax 169 (771) 314 (771)
Net (loss) (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (130,827) (41,117) (300,886) 184,474

Net comprehensive (loss) (2,711,535) (3,891,375) (6,898,369) (7,217,622)
Basic and diluted (loss) per common share (0.02) (0.03) (0.06) (0.07)
Weighted average number of shares (basic and diluted) 119,601,638 114,549,532 118,900,812 107,095,007

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193
Net loss and comprehensive loss — — 184,474 (7,402,096) (7,217,622)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,053,525 — — — 19,053,525
Share based compensation — 170,645 — — 170,645
As at June 30, 2015 261,015,977 26,019,074 464,517 (257,368,431) 30,131,137


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2015 261,324,692 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and comprehensive loss — — (300,886) (6,597,483) (6,898,369)
Issued, pursuant to "At the Market" Agreement 609,830 — — — 609,830
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
Share based compensation — 201,266 — — 201,266
As at June 30, 2016 261,975,522 26,438,232 460,092 (270,286,813) 18,587,033

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

Three Month
Period Ending
June 30,
2016
$ Three Month
Period Ending
June 30,
2015
$ Six Month
Period Ending
June 30,
2016
$ Six Month
Period Ending
June 30,
2015
$

Operating Activities
Net loss for the period (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Amortization – property and equipment 44,675 44,852 90,617 89,982
Share based compensation 119,626 55,675 201,266 170,645
Unrealized foreign exchange loss (gain) (243,914) 1,634 (102,619) (303,522)
Net change in non-cash working capital 37,581 (1,370,187) 762,236 (420,482)
Cash used in operating activities (2,622,740) (5,118,284) (5,645,983) (7,865,473)
Investing Activities
Acquisition of property and equipment (5,702) (17,657) (5,702) (29,597)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (5,702) (17,657) (33,525) (58,889)
Financing Activities
Proceeds from Share Purchase Agreement — 2,379,800 — 4,305,396
Proceeds from "At the Market" equity distribution agreement 710,374 4,416,607 609,830 19,053,525
Cash provided by financing activities 710,374 6,796,407 609,830 23,358,921
Increase (decrease) in cash (1,918,068) 1,660,466 (5,069,678) 15,434,559
Cash and cash equivalents, beginning of period 20,233,408 28,578,023 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 5,641 (220,272) (625,616) 430,833
Cash and cash equivalents, end of period 18,320,981 30,018,217 18,320,981 30,018,217

To view the Company’s Fiscal 2016 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source

On August 4, 2016 Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, reported that the Company has discontinued further accrual in its Phase 2 trial evaluating necuparanib in combination with Abraxane and gemcitabine in patients with advanced metastatic pancreatic cancer (Press release, Momenta Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514227]).

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The decision to discontinue enrollment into the study was based on the recommendation from the independent Data Safety Monitoring Board (DSMB) following a planned interim futility analysis conducted once 57 deaths (50% of the target number of 114 events required for trial completion) had occurred. Data were assessed from 120 randomized patients as of July 20, 2016. While no new safety signals were observed and the toxicity profile was considered manageable, the DSMB determined that necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment. Additionally, no new toxicities were observed that necessitate immediate discontinuation of study drug in patients currently active on protocol. The DSMB also recommended that the company consider unblinding the data to provide more information to determine how best to address ongoing patients.

"We are extremely disappointed with the outcome of the futility analysis – in particular, for those patients with pancreatic cancer where there is still so much unmet need for safe and effective therapy," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "We agree with the DSMB recommendations and plan to confirm the futility analysis and determine next steps for the necuparanib program."

"We are saddened that necuparanib did not produce the outcome we had hoped for in this patient population," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We would like to thank the investigators and their brave patients for participating in this trial as well as our staff and external advisors for their support throughout this program."

The Phase 1/2 necuparanib trial is a two-part study in patients with advanced metastatic pancreatic cancer. Part A was a Phase 1, open-label, multiple ascending dose study of necuparanib given first as a single dose and then daily in combination with Abraxane and gemcitabine; final data from Part A was reported at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting. Part B is a Phase 2, randomized, placebo-controlled, double-blind study investigating the antitumor activity of necuparanib combined with Abraxane and gemcitabine compared with placebo combined with Abraxane and gemcitabine.

About Necuparanib
Necuparanib (M402) is a novel oncology drug candidate engineered to have a broad range of effects on tumor cells. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. Leveraging its experience in deciphering the structure-function relationships of complex therapeutics, Momenta engineered necuparanib from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins.

On August 4, 2016 Acceleron Pharma Inc. (NASDAQ: XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of highly innovative therapeutics to treat serious and rare diseases, reported a corporate update and reported financial results for the second quarter ended June 30, 2016 (Press release, Acceleron Pharma, AUG 4, 2016, View Source [SID:1234514228]).

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"In the second quarter, we presented updated luspatercept data that builds upon the encouraging Phase 2 results and we have also reinforced the initial results with ACE-083 by showing impressive increases in muscle volume in the second muscle studied in the Phase 1 clinical trial," said John Knopf, Ph.D., Chief Executive Officer of Acceleron. "With luspatercept now in two Phase 3 clinical trials, ACE-083 heading toward its first Phase 2 clinical trial in the second half of 2016, a rapidly expanding and advancing pipeline of preclinical programs and capital to finance the Company into the second half of 2019, Acceleron is well-positioned for both near- and long-term growth."

SECOND QUARTER 2016 HIGHLIGHTS

Development Programs

Hematology

• Updated results from ongoing luspatercept Phase 2 clinical trial in myelodysplastic syndromes (MDS) presented at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) confirm activity and durability of response. Results highlighted in an oral presentation showed that 51% (25/49) of patients with lower-risk MDS treated with luspatercept achieved increased hemoglobin levels, and 35% (14/40) of patients achieved transfusion independence in the 3-month base study. In the ongoing extension study, 81% (26/32) of patients had increased hemoglobin levels and 50% (11/22) achieved transfusion independence with luspatercept treatment. Data was presented showing hemoglobin increases being sustained for 15 months.

• Updated results from ongoing luspatercept Phase 2 clinical trial in beta-thalassemia also presented at EHA (Free EHA Whitepaper). Results presented showed that 67% (20/30) of patients achieved at least a 33% reduction in transfusion burden, and 36% (8/22) of patients achieved a hemoglobin increase of at least 1.5 g/dL in the luspatercept 3-month base study. In the ongoing long-term extension study, 83% (20/24) of patients achieved at least a 33% reduction in transfusion burden and 56% (15/27) of patients achieved a hemoglobin increase of at least 1.5 g/dL. Data was presented showing hemoglobin increases being sustained for 12 months.

• Enrollment is ongoing to explore luspatercept activity in low- or intermediate-risk MDS patients who are erythropoiesis-stimulating agent (ESA) naïve or ring sideroblast negative (RS-). Patients who are eligible to be treated with an ESA but have not yet received such treatment or who are RS-, are being enrolled in a Phase 2 clinical trial. Acceleron plans to present the initial data from these patients by the end of the year.

Musculoskeletal Diseases

• Results from Phase 1 study of ACE-083 in healthy volunteers were presented at the International Congress on Neuromuscular Diseases. Results demonstrated that ACE-083 produced statistically significant, dose-dependent increases in muscle volume, assessed by magnetic resonance imaging (MRI), of the tibialis anterior muscle. At the highest dose level, ACE-083 generated a mean increase in muscle volume of 8.9% (p<0.001 vs placebo).

• Progress continues toward the initiation of a Phase 2 trial with ACE-083 in facioscapulohumeral muscular dystrophy (FSHD), a neuromuscular disorder, in the second half of 2016.

Nephrology

• Acceleron and Celgene expect to provide a development plan update for sotatercept in the second half of 2016. The companies met with health authorities in the first half of the year as part of assessing the potential future investigation of sotatercept in patients with pre-dialysis chronic kidney disease (CKD) due to diabetic nephropathy.

Oncology

• Enrollment continues in Part 2 of the Phase 2 DART study, a randomized, double-blind study of dalantercept plus axitinib, compared to placebo plus axitinib in patients with advanced renal cell carcinoma (RCC). The primary endpoint of this trial, progression-free survival (PFS), is an event-driven assessment with data potentially available by the end of the year.

Preclinical Research

• Acceleron continues its research on several molecules targeting musculoskeletal diseases, fibrotic disorders and other serious diseases. The most advanced molecule from the IntelliTrap platform, ACE-2494, continues to advance through IND-enabling activities. The Company plans to initiate a Phase 1 clinical trial with ACE-2494 in the first half of 2017.

Other Corporate Updates

• Thomas McCourt appointed to Acceleron’s board of directors. Mr. McCourt brings 30 years of experience building commercial strategies and capabilities across multiple companies for new therapies. He serves as chief commercial officer and senior vice president of marketing and sales of Ironwood Pharmaceuticals. Prior to joining Ironwood in 2009, Mr. McCourt held commercial roles at Amgen, Novartis AG and Astra Merck Inc.
Financial Results

• Cash position – Cash, cash equivalents and investments as of June 30, 2016 were $262.7 million. As of December 31, 2015 the Company had cash, cash equivalents and investments of $136.0 million. The Company believes that existing cash, cash equivalents and investments will be sufficient to fund its projected operating requirements into the second half of 2019.

• Revenue – Collaboration revenue for the second quarter was $3.2 million. License and milestone revenue was $0.1 million. Cost sharing reimbursement revenue from the Company’s Celgene partnership was $3.1 million and is related to expenses incurred by the Company in support of its partnered programs.

• Costs and expenses – Total costs and expenses for the second quarter were $22.8 million. This includes R&D expenses of $16.1 million and G&A expenses of $6.7 million.

• Other expense, net – Other expense for the second quarter was $2.4 million and includes a $2.9 million, non-cash, loss on marking the Company’s common stock warrant liability to market.

• Net loss – The Company posted a net loss for the second quarter ended June 30, 2016 of $22.0 million.

On August 4, 2016 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the second quarter ended June 30, 2016 (Press release, Momenta Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514248]).

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For the second quarter of 2016, the Company reported total revenues of $26.4 million, including $20.7 million in product revenues from Sandoz’s sale of Glatopa (glatiramer acetate injection). Momenta reported a net loss of $(21.0) million, or $(0.31) per share for the second quarter compared to a net loss of $(2.2) million, or $(0.04) per share for the same period in 2015. At June 30, 2016, the Company had cash, cash equivalents, and marketable securities of $336.9 million compared to $362.8 million at March 31, 2016.

"We are pleased with the growth in product revenues from Glatopa this quarter and look forward to the potential launch of our Glatopa 40 mg product next year," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "During the remainder of 2016 we plan to announce several key milestones including announcing top-line data from a pivotal trial for M923, a biosimilar candidate of HUMIRA developed in collaboration with Baxalta, the initiation of a clinical trial for M834, a biosimilar candidate of ORENCIA being developed in collaboration with Mylan, and completing enrollment of the single ascending dose portion of our Phase 1 trial for M281, a novel anti-FcRn antibody candidate."

Second Quarter Highlights and Recent Events

Complex Generics:

In the second quarter of 2016, Momenta recorded $20.7 million in product revenues from Sandoz’s Glatopa sales.
The ANDA submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection) is under FDA review. The Company expects to receive tentative regulatory approval in 2016.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) is scheduled for September 26, 2016.
Biosimilars:

In April 2016, Momenta and its collaboration partner Baxalta, now a part of Shire, completed enrollment in the pivotal clinical trial for M923, a biosimilar candidate of HUMIRA (adalimumab) and the companies expect to release results in late 2016. The companies are targeting first regulatory submission for marketing approval in 2017 and a first commercial launch as early as 2018.
Momenta’s global collaboration with Mylan to develop, manufacture and commercialize six of the Company’s biosimilar candidates is progressing. The companies have prioritized three lead programs including M834, a biosimilar candidate of ORENCIA (abatacept).
Novel Drugs:

Necuparanib (novel oncology candidate)

On August 3, 2016, the Data Safety Management Board recommended that the Company discontinue further accrual in the Phase 2 trial of necuparanib in pancreatic cancer following the outcome of a planned interim futility analysis. The Company plans to confirm the futility analysis and then determine next steps for the necuparanib program.
Autoimmune Drugs
Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. In June 2016, the Company initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2016 Financial Results

Total revenues for the second quarter of 2016 were $26.4 million compared to $44.9 million for the same period in 2015. Total revenues for the second quarter of 2016 include $20.7 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $19.2 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. Glatopa was launched in the second quarter of 2015, and Glatopa profit share for that quarter was reduced by $9.0 million to reimburse Sandoz for the Company’s share of pre-launch Glatopa-related legal expenses.

Collaborative research and development revenue for the second quarter of 2016 was $5.7 million compared to the $25.6 million recorded in the same quarter last year. In the second quarter of 2015, the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon the first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2016 were $33.2 million, compared to $34.0 million for the same period in 2015. The decrease of $0.8 million, or 2%, from the 2015 period to the 2016 period was due to decreases of $0.8 million in stock-based compensation expense and $8.4 million for Mylan’s 50% share of biosimilar collaboration costs, which was offset by increases of $4.4 million in process and clinical development costs for M281 and biosimilars under the Company’s collaboration with Mylan, $2.2 million in non-clinical expenses to advance the Company’s novel autoimmune programs, $1.0 million in personnel-related expenses and $0.7 million in necuparanib Phase 2 clinical trial costs.

General and administrative expenses for the quarter ended June 30, 2016 were $14.9 million, compared with $13.3 million for the same period in 2015. The increase of $1.6 million, or 12%, was primarily due to an increase of $2.1 million in legal and professional fees. This increase was offset by a decrease of $0.5 million for Mylan’s 50% share of biosimilar collaboration costs.

At June 30, 2016, Momenta had $336.9 million in cash, cash equivalents and marketable securities.

Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Today, Momenta reiterated its non-GAAP operating expense guidance of approximately $40 – $45 million per quarter for the second half of 2016. Non-GAAP operating expense is total operating expenses (which is net of Mylan’s share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta. The quarterly recognition of collaborative revenues under the Company’s collaborations with Baxalta and Mylan is expected to be $2.4 million and $1.8 million per quarter, respectively.

On August 4, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial and business results for the second quarter 2016 (Press release, Progenics Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514291]).

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"The clear highlight in recent weeks was the approval of RELISTOR tablets, which triggered a $50 million milestone payment from our partner Valeant, strengthening our balance sheet as we prepare for a potential AZEDRA launch and continue to advance development of our prostate cancer pipeline," said Mark Baker, Chief Executive Officer of Progenics. "Our cash, together with the potential to earn significant additional royalties and sales milestones from the RELISTOR franchise, puts us in a strong position to achieve multiple value-creating milestones. In particular, our ultra-orphan radiotherapeutic candidate AZEDRA represents a meaningful near-term commercialization opportunity for Progenics, and we are on track to announce registrational topline data later this year or in early 2017. We are also advancing development of our portfolio of prostate cancer imaging agents and therapeutics, which has the potential to significantly improve how we find, fight, and follow all stages of prostate cancer."

Key Business Highlights

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

On July 19, the Company Announced that the FDA has approved RELISTOR tablets for the treatment of opioid induced constipation in adults with chronic non-cancer pain. The approval triggered a $50 million milestone payment on July 25 from Progenics’ partner, Valeant, as well as subsequent royalties and up to $200 million in sales milestones.

RELISTOR SC Net Sales for the Second Quarter 2016 Total $15.9 Million. The second quarter 2016 sales, as reported to the Company by Valeant, translated to $2.4 million in royalty revenue for the second quarter of 2016.
AZEDRA, Ultra-orphan radiotherapeutic candidate

AZEDRA Topline Results Expected Between December 2016 and March 2017. In late 2016 or early 2017, Progenics expects to report topline results from its ongoing registrational trial of AZEDRA. If the AZEDRA trial meets the endpoints of the SPA, the Company expects to submit an NDA to the FDA during the first half of 2017.
PSMA-Targeted Prostate Cancer Pipeline

Granted an Exclusive License to Bayer for the Development and Commercialization of Therapeutic Antibodies Combining Progenics’ PSMA Antibody Technology with Bayer’s Targeted Thorium Conjugate Technology. Progenics recognized revenue of $5 million in the second quarter of 2016, constituting the $4 million upfront payment and the first pre-clinical development milestone of $1 million. Under terms of the agreement, the Company is entitled to up to an additional $48 million in potential clinical and regulatory development milestones, single digit royalties on net sales, and potential sales milestone payments up to an aggregate of $130 million.

Enrollment in Pivotal Phase 3 Study of 1404 is Ongoing. The study will enroll up to 450 patients with newly-diagnosed or low-grade prostate cancer who are candidates for active surveillance. The Company’s plans for an interim analysis during the fourth quarter of 2016 to assess futility and evaluate the need for a sample size re-estimation remain unchanged.

Presented Data from its PSMA-Targeted Prostate Cancer Imaging Programs at the Society of Nuclear Medicine and Molecular Imaging 2016 Annual Meeting in San Diego. The data highlighted the potential of the Company’s SPEC/CT imaging agent 1404 and PET/CT imaging agent PyL to detect prostate cancer.

On-Track to Initiate Phase 2/3 Trial of PyL by Year-End. The study is designed to assess the diagnostic accuracy of PyL PET/CT imaging in patients with high risk and/or metastatic prostate cancer.

Company Remains On-Track to Initiate a Phase 1 Trial of 1095 in the Fourth Quarter of 2016. The Phase 1 Study of 1095, a PSMA-Targeted Therapeutic for Metastatic Prostate Cancer, will be conducted at Memorial Sloan Kettering Cancer Center.
Second Quarter 2016 Financial Results

Net loss attributable to Progenics for the quarter was $5.6 million or $0.08 per diluted share, compared to a net loss of $11.7 million or $0.17 per diluted share in the 2015 period. Progenics ended the quarter with cash and cash equivalents of $60.1 million, a decrease of $5.5 million in the quarter.

Second quarter revenue totaled $8.5 million, up from $1.9 million in 2015, reflecting RELISTOR royalty income of $2.4 million compared to $1.8 million in the 2015 period, based on net sales reported to Progenics by Valeant. The increase was primarily attributable to upfront and milestone revenue of $5 million under the Bayer license agreement.

Second quarter and year-to-date research and development expenses increased by $1.3 million and $3.9 million, respectively, compared to the prior year periods, resulting from higher clinical trial and contract manufacturing expenses for AZEDRA, 1404 and PyL, partially offset by lower expenses for PSMA ADC. Second quarter general and administrative expenses decreased by $0.5 million from the prior year period, primarily attributable to lower legal fees as the prior year included costs related to litigation with a former employee. Year-to-date general and administrative expenses increased by $1.6 million compared to prior year period, primarily resulting from higher depreciation expense as a result of a reduction in the remaining useful lives of our leasehold improvements at our Tarrytown, NY location, and higher compensation and consulting expenses. The Company also recorded a non-cash charge of $0.6 million in the second quarter related to an increase in the fair value estimate of the contingent consideration liability.