On May 2, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported its first quarter 2016 financial results (Press release, Merrimack, MAY 2, 2016, View Source [SID:1234511803]).

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Merrimack will host a live conference call and webcast today, Monday, May 2 at 4:30 p.m., Eastern time, to provide an update on Merrimack’s progress as well as a summary of these results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 90717802. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

ONIVYDE (irinotecan liposome injection) Update

Merrimack received approval for ONIVYDE from the U.S. Food and Drug Administration on October 22, 2015 and launched ONIVYDE in the United States on October 26, 2015;
In March 2016, the ONIVYDE regimen was added to the National Comprehensive Cancer Network (NCCN) 2016 Clinical Practice Guidelines in Oncology as a Category 1 Treatment Option for patients with metastatic pancreatic adenocarcinoma who have previously been treated with gemcitabine-based therapy; and
Gross product revenues from U.S. commercial sales of ONIVYDE for the first quarter of 2016 were $11.3 million, while net product revenues were $10.0 million.
Key Recent Events

Merrimack’s key recent events include:

Completion of the safety portion and transition to part two of the Phase 2 clinical study of MM-141 in patients with front-line metastatic pancreatic cancer;
Unveiling of Merrimack’s latest antibody directed nanotherapeutic (ADN), MM-310, and presentation of clinical and preclinical research demonstrating advances across Merrimack’s extensive oncology pipeline, including ONIVYDE, MM-302, MM-310, MM-141 and MM-151, at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting; and
Announcement of a strategic partnership with Leica Biosystems to develop Merrimack’s novel heregulin assay for seribantumab (MM-121) into a kit for commercial use.
Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

Results in 2017 from the Phase 2 clinical study of ONIVYDE in previously untreated front-line metastatic pancreatic cancer;
Results in 2017 from HERMIONE, the Phase 2 clinical study of MM-302 in patients with HER2-positive metastatic breast cancer that is designed to support a potential Accelerated Approval application to the FDA;
Results in 2018 from the Phase 2 clinical study of MM-141 in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1; and
Results in 2018 from the Phase 2 clinical study of MM-121 in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer that is designed to support a potential Biologics License Application to the FDA.
First Quarter 2016 Financial Results

The following summarizes Merrimack’s financial results from the quarter ended March 31, 2016:

Product revenues from the commercial sale of ONIVYDE, net of discounts, allowances and reserves, were $10.0 million for the first quarter of 2016, compared to $4.3 million for the fourth quarter of 2015. This represents an increase of $5.7 million, or 133%, over the prior quarter;
License and collaboration revenues were $11.3 million for the first quarter of 2016, compared to $17.1 million for the fourth quarter of 2015. This represents a decrease of $5.8 million from the prior quarter. This revenue was recognized under the proportional performance revenue recognition model, and the decrease is due to the timing of work performed under Merrimack’s Baxalta collaboration;
Aggregate research and development and selling, general and administrative expenses were $50.7 million for the first quarter of 2016, compared to $64.1 million for the fourth quarter of 2015. This represents a decrease of $13.4 million, or 21%, which was made up of the following:
$11.9 million of decreased research and development expenses due primarily to one-time drug purchases that occurred in the fourth quarter of 2015 as well as the wind down and close out of various clinical trials in the first quarter of 2016; and
$1.5 million of decreased selling, general and administrative expenses due to increased costs related to the launch of ONIVYDE in the fourth quarter of 2015;
Interest expense for the first quarter of 2016 was $8.6 million, compared to $5.7 million for the fourth quarter of 2015. This $2.9 million increase was due to the new 11.5% senior secured notes due 2022 issued in the fourth quarter of 2015; and
Net loss attributable to Merrimack for the first quarter of 2016 was $38.5 million, or $0.33 per share, compared to a net loss attributable to Merrimack of $47.8 million, or $0.41 per share, for the fourth quarter of 2015.
2016 Financial Outlook

Merrimack reiterates the following fiscal 2016 guidance:

Receipt of $46.5 million of net milestone payments related to ONIVYDE. This amount is made up of $36.5 million of net substantive milestones expected to increase net income in 2016 and $10.0 million of net non-substantive milestones expected to increase deferred revenues on Merrimack’s balance sheet, as they are included in the Baxalta proportional performance revenue recognition model; and
Aggregate research and development and selling, general and administrative expenses to be in the range of $225 million to $245 million, not including any one time payments to PharmaEngine.
Merrimack 2016 Analyst Day

Merrimack will host an Analyst Day on May 19, 2016 in New York for analysts and institutional investors, where it will provide an update on Merrimack’s pipeline, including the development plan for ONIVYDE. In attendance will be key members of Merrimack’s science and clinical teams, as well as featured guest speaker Charles Fuchs, M.D., M.P.H., of Dana-Farber Cancer Institute, who will speak on the gastrointestinal cancer space.

A live webcast of the event will be available in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the webcast will be archived there for six weeks.

Upcoming Investor Conferences

Merrimack will attend the following investor conferences in the coming months:

Deutsche Bank Securities 41st Annual Healthcare Conference on May 4 in Boston; and
Wells Fargo Securities Biotech Corporate Access Day on July 26 in Boston.
A live webcast of the presentation at the Deutsche Bank Securities 41st Annual Healthcare Conference can be accessed by visiting the Investors section of Merrimack’s website at investors.merrimack.com. A replay of the webcast will be archived there for two weeks following the presentation.

On May 02, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) granted orphan drug designations to Kite’s lead product candidate, KTE-C19, for the treatment of primary mediastinal B cell lymphoma (PMBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL) (Press release, Kite Pharma, MAY 2, 2016, View Source [SID:1234511757]). Kite previously received orphan drug designation for KTE-C19 for the treatment of diffuse large B cell lymphoma (DLBCL) in both the U.S. and the EU, as well as orphan drug designations in the EU for PMBCL, MCL, FL, ALL, and CLL.

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"Kite has now secured Orphan Drug Designations in both the U.S. and the EU for the leading indications in hematological malignancies. This is an important regulatory milestone as we further our development of KTE-C19 in advanced hematological cancers, including the planned initiation of clinical studies in CLL and FL patients in 2017," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "We are encouraged by the progress of our four ongoing ZUMA clinical trials and our ability to manufacture clinical supply of KTE-C19 in our own Santa Monica facilities. We look forward to working closely with the FDA to bringing this potentially transformative therapy to patients with a significant unmet need."

Orphan drug designation is granted by the FDA’s Office of Orphan Products Development (OOPD) to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The OOPD provides incentives for sponsors to develop products for rare diseases which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same biologic for the same indication for seven years, except in limited circumstances.

On May 2, 2016 BioInvent International (BINV) reported it has initiated a Phase I/IIa study that will evaluate the safety and tolerability, and explore the preliminary efficacy, of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children (Press release, BioInvent, MAY 2, 2016, View Source [SID:1234511754]).

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Today’s study initiation follows the earlier announced partnership between BioInvent, its TB-403 project partner Oncurious, and the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) in the US. NMTRC is a collaboration of 25 US academic medical centers, teaching hospitals and other entities, with the purpose of facilitating and conducting collaborative research activities and investigations of new treatments for neuroblastoma, medulloblastoma and other pediatric cancers.

Headquartered at the Helen DeVos Children’s Hospital in Grand Rapids, MI, USA, NMTRC is the key clinical trial partner for this Phase I/IIa study. The study aims at recruiting a minimum of 27 patients, with first results expected to be reported in 2017.

TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF) which is expressed in several types of cancer, including medulloblastoma. A paper in Cell in February 2013 (Cell, 152, 1065-76, 2013), highlighted for the first time that PlGF plays a role in the growth and spread of medulloblastoma. The paper was based on pre-clinical research conducted by Prof Rakesh Jain from the Massachusetts General Hospital at Harvard Medical School (Boston) and the team of Prof Peter Carmeliet from Vesalius Research Center, VIB Katholieke Universitiet, Leuven, Belgium.

Treatment with TB-403 in pre-clinical models for medulloblastoma has demonstrated beneficial effects on tumor growth and survival. TB-403 has been shown to have a favorable safety profile in previous clinical trials in healthy volunteers and adult patients with various types of solid tumors.

The drug candidate TB-403 is jointly owned by BioInvent and the Belgian biopharma company Oncurious NV.

Michael Oredsson, CEO of BioInvent commented, "The initiation of this study is a key step in the development of this new targeted potential treatment for children with devastating brain cancers. We are looking forward to be working with NMTRC’s experienced investigator network to complete this study in a timely manner."

Dr Patrik De Haes, Executive Chairman of Oncurious, commented, "We are pleased to announce the initiation of this important Phase I/IIa study with TB-403, a key corporate milestone for Oncurious. Given the encouraging pre-clinical data generated with TB-403 in Leuven and Boston, we are hopeful that this novel antibody, targeting placental growth factor, will provide an improved treatment option for children afflicted with this lethal brain tumor."

Giselle Sholler, MD MSC, of NMTRC, commented, "We are delighted to be starting this study, which is very much in line with our mission to bring forward new therapies that could improve the quality of life and survival of children with medulloblastoma. We believe that with its unique mode of action TB-403 could offer an important solution to address this tremendous unmet medical need."

On May 02, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has granted an exclusive license to Bayer for the development and commercialization of therapeutic antibodies combining the Company’s prostate specific membrane antigen (PSMA) antibody technology with Bayer’s targeted thorium conjugate technology (Press release, Progenics Pharmaceuticals, MAY 2, 2016, View Source [SID:1234511743]).

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"While there have been recent advances in the treatment of prostate cancer, there remains a great need for therapies that can more specifically target primary and metastatic prostate cancer," said Mark R. Baker, Chief Executive Officer of Progenics. "This license agreement with Bayer further validates the value of our PSMA antibody technology in the development of targeted cancer treatments. We are pleased that Bayer recognizes the potential of our technology."

PSMA is a protein that has been found to be amplified on the surface of >95% of prostate cancer cells and is a validated target for the detection of primary and metastatic prostate cancer. Antibody-thorium conjugates are comprised of a radioactive alpha emitter, thorium-227, linked to an antibody, in this case PSMA. The thorium conjugates bind to the surface of tumor cells and emit alpha particles that destroy tumor cells by inducing DNA double-strand breaks, with no need for uptake into the cells for efficacy.

Per the terms of the license agreement, Progenics will receive an upfront fee and could receive additional potential clinical and regulatory development milestones. If approved, Progenics is entitled to single digit royalties and sales milestone payments.