On February 29, 2016 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the year ended December 31, 2015 (Press release, MacroGenics, FEB 29, 2016, View Source [SID:1234509310]).

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"I am thrilled with MacroGenics’ progress towards advancing breakthrough biologics and life-changing medicines, and particularly our industry leadership in creating bi-specific molecules," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "There are now six Dual-Affinity Re-Targeting, or DART, molecules based on our proprietary platform, in or entering clinical development — four led by MacroGenics and two led by our collaborators, Janssen Biotech and Pfizer. In addition, we are actively enrolling patients with metastatic breast cancer in SOPHIA, our Phase 3 study of our Fc-optimized HER2 antibody, margetuximab. During 2015, in addition to updating our Phase 1 margetuximab data at the ASCO (Free ASCO Whitepaper) annual meeting, we also reported encouraging initial results from an ongoing Phase 1 study of enoblituzumab, our Fc-optimized B7-H3 antibody, at the SITC (Free SITC Whitepaper) annual meeting. Finally, given the strength of our cash and investments balance, we continue to be well positioned to advance our proprietary pipeline of immunotherapeutic product candidates."

"For 2016, we have already initiated a Phase 1b/2 study combining margetuximab and pembrolizumab in advanced HER2-positive gastric cancer," added Dr. Koenig. "Later this year, we plan to share additional enoblituzumab clinical data and provide clinical updates on multiple DART molecules being evaluated in Phase 1 studies. We also expect to submit an Investigational New Drug (IND) application for MGA012. Over the next few years, we intend to continue to advance at least one additional IND per year."

Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2. Recent highlights include:

Phase 1b/2 Gastric Cancer Study: MacroGenics recently dosed the first patient in a Phase 1b/2 clinical trial of margetuximab in combination with pembrolizumab, an anti-PD-1 therapy, in patients with advanced HER2-positive gastric cancer. Treatment options for these patients are limited and our proposed combination regimen would avoid chemotherapy while exploiting the expected enhanced immune-mediated killing properties of both margetuximab and pembrolizumab. We recently elected to expand the scope of this trial to include centers in both Asia and the United States. This study is being conducted in collaboration with Merck.
SOPHIA Study: The Company’s Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is ongoing, as the Company continues to initiate sites and enroll patients. This study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 patients following progression after at least two lines of previous therapy. The Company is targeting completion of this study in 2018.

B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action and take advantage of this antigen’s broad expression across multiple solid tumor types. Recent highlights of ongoing clinical programs include:

Enoblituzumab (MGA271): Data from the ongoing monotherapy study of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3, was presented in a late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November. Enoblituzumab has been generally well tolerated in patients and has shown encouraging initial single-agent, anti-tumor activity in heavily pre-treated patients, including those with prostate and bladder cancer as well as melanoma. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company has expanded its development program to include two combination studies with either ipilimumab or pembrolizumab.
MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types.

DART Product Candidates. There are currently six DART molecules in or entering Phase 1 clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3, also known as JNJ-64052781), MGD010 (CD32B x CD79B), MGD009 (B7-H3 x CD3) and PF-06671008 (P-cadherin x CD3). The Company expects to submit IND applications for two additional DART molecules in 2017. These two product candidates are:

MGD013: MacroGenics is developing an Fc-bearing DART molecule, MGD013, to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3. The Company has presented promising pre-clinical data demonstrating the activity of a DART molecule with these specificities and expects that this bi-specific combination may be useful for treatment of a wide range of solid tumors and hematological malignancies.
MGD014: In 2015, MacroGenics presented pre-clinical data on MGD014, a DART molecule that is being developed to eliminate latent HIV infection. MGD014 is being developed under a contract awarded to MacroGenics by the National Institute of Allergy and Infectious Diseases for up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.

Beyond MGD013 and MGD014, MacroGenics is generating and evaluating multiple other candidates that target a range of immune regulatory and other molecules using both its DART and Trident platforms, the latter for generating tri-specific molecules.

Corporate Update

Commercial Preparation: Tom Farrell recently joined MacroGenics as Vice President, Market Development and Strategy and will lead the Company’s effort in preparing for commercialization of its lead product candidates. Tom was most recently at Genentech, a Member of the Roche Group, where he was Global Pricing & Market Access Head (Oncology/Hemophilia), and responsible for leading the development and implementation of global pricing and payer strategies for all oncology (including Perjeta and Kadcyla) and hemophilia molecules from early- through late-stage development.
Pfizer’s DART Molecule Advances: MacroGenics’ collaboration partner, Pfizer, recently advanced PF-06671008, a DART molecule that targets P-cadherin and CD3, by submitting an IND application that has been cleared by the FDA. Increased levels of the protein P-cadherin have been reported in various tumors, including breast, gastric, endometrial, colorectal and pancreatic cancers, and is correlated with poor survival of patients.

2015 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and investments as of December 31, 2015 were $339.0 million, compared to $157.6 million as of December 31, 2014. In the first quarter of 2015, MacroGenics closed a global collaboration and license agreement for MGD011 with Janssen Biotech, Inc. and received a $50 million upfront license fee. Johnson & Johnson Innovation – JJDC, Inc. also purchased $75 million of newly issued shares of MacroGenics common stock. In July 2015, MacroGenics completed an equity offering that raised net proceeds of $141 million.

Revenue: Total revenues, consisting primarily of revenue from collaborative agreements, were $100.9 million for the year ended December 31, 2015, compared to $47.8 million for the year ended December 31, 2014. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.

R&D Expenses: Research and development expenses were $98.3 million for the year ended December 31, 2015, compared to $70.2 million for the year ended December 31, 2014. This increase was due primarily to the initiation of SOPHIA, a margetuximab Phase 3 study, and a Phase 1b/2 study of margetuximab in combination with pembrolizumab, increased activity in our pre-clinical immune checkpoint programs, including MGD013, and the initiation of a Phase 1a study of MGD010.

G&A Expenses: General and administrative expenses were $22.8 million for the year ended December 31, 2015, compared to $15.9 million for the year ended December 31, 2014. This increase was primarily due to higher labor-related costs, including stock-based compensation expense and information technology-related expenses.

Net Loss: Net loss was $20.1 million for the year ended December 31, 2015, compared to a net loss of $38.3 million for the year ended December 31, 2014.

Shares Outstanding: Shares outstanding as of December 31, 2015 were 34,345,754.

Financial Guidance: MacroGenics expects that its current cash, cash equivalents and investments, combined with anticipated funding under its strategic collaborations, should fund the Company’s operations into 2018.

On February 29, 2016 Incyte Corporation (Nasdaq: INCY) announced that they have joined the European Organization for Rare Diseases (EURODIS), the National Organization for Rare Disorders (NORD) and other rare disease health organizations and advocates in recognizing the ninth annual Rare Disease Day 2016 (Press release, Incyte, FEB 29, 2016, View Source;p=RssLanding&cat=news&id=2144192 [SID:1234509267]).

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"Rare Disease Day offers a time for patients, physicians, caregivers and advocates to join together to honor those with rare diseases across the globe, among them an estimated 200,000 individuals in the U.S. living with a group of rare blood cancers known as myeloproliferative neoplasms (MPNs)," said Steven Stein, Chief Medical Officer, Incyte Corporation.
MPNs are a closely related group of progressive blood cancers that can strike anyone at any age. MPNs occur when the bone marrow cells that produce the body’s blood cells develop and function abnormally. The three main MPNs are myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET).

This year’s Rare Disease Day theme, Patient Voice, highlights the impact patient voices have on quality care and treatment and the importance of patient and caregiver voices in the broader community to raise awareness for rare diseases. In keeping with this theme, Incyte shares story highlights from three patients from our "Voices of MPN" program.
"One of the first things I would tell someone who is newly diagnosed with a rare disease, is to be your own advocate," shares Aimee Akins, a PV patient and advocate. "I was diagnosed in October 2013 with polycythemia vera (PV). It was a long journey as I had been going to doctors since 2008. It wasn’t until I became my own advocate and looked into finding my own specialist that things really started to come together for me."

Rare Disease Day also provides an opportunity to honor patients, doctors, caregivers, advocates and organizations that contribute to bringing understanding, compassion and strength to those living with MPNs through the MPN Heroes Recognition Program 2016. Now in its fifth year, the MPN Heroes program, sponsored by Incyte in collaboration with CURE Media Group, publishers of CURE magazine, recognizes individuals and organizations who have contributed to the MPN community by going above and beyond to make a real difference. Our goal is to create as many opportunities as possible for people with MPNs to be heard and to be supported, so more solutions and treatment options will emerge. Nominations for the 2016 MPN Heroes program are now being accepted online and via email until September 8, 2016. Visit www.MPNHeroes.com for more details.

Share Your Voice and Find More Resources at Voices of MPN:
The Voices of MPN website features patients and caregivers sharing their stories; links to disease information, educational programs and patient support groups; and a "Raise Your Voice" Toolkit which provides tips on how to help spread awareness within the community.

Stay connected and informed with all of the MPN awareness activities happening throughout September by "Liking" the "Voices of MPN" Facebook page or following "Voices of MPN" on Pinterest.

On February 29, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported that it has entered into a collaboration agreement with Merck, known as MSD outside the US and Canada, through a subsidiary, to develop and commercialize a novel diagnostic assay to predict response to KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, NanoString Technologies, FEB 29, 2016, View Source [SID:1234509311]). Under the terms of the collaboration agreement, NanoString will be responsible for seeking regulatory approval for and commercialization of the diagnostic test. NanoString will be eligible to receive up to $24 million for technology access and near-term milestones, in addition to development funding and other potential regulatory milestone payments.

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Previously, the companies had engaged in a research collaboration to develop an assay to evaluate the potential to predict benefit from KEYTRUDA. The expanded collaboration is for the development and commercialization of the selected gene expression signature on NanoString’s nCounter Dx Analysis System as a diagnostic assay to predict response to KEYTRUDA in multiple tumor types.

"We look forward to working with NanoString on the development of their diagnostic assay to help identify patients who are most likely to benefit from KEYTRUDA in multiple additional tumor types," said Dr. Eric Rubin, vice president, oncology early-stage development, Merck Research Laboratories.

"We are excited to expand our collaboration with Merck to develop this novel assay for predicting response to anti-PD-1 therapies such as KEYTRUDA. We believe this gene signature has the potential to become the basis for a universally available assay that serves as the ‘gold standard’ for informing treatment with immuno-oncology therapies," said Brad Gray, President and Chief Executive Officer of NanoString Technologies. "This collaboration solidifies NanoString’s position as the leader in immuno-oncology biomarker signatures, and builds on our ongoing research collaborations with MD Anderson and the Cancer Immunotherapy Trials Network."

Under the terms of the expanded collaboration agreement, NanoString retains the flexibility to independently develop and commercialize additional indications for the resulting diagnostic assay. In particular, this signature could form the basis for a comprehensive immuno-oncology test with the ability to direct use of multiple therapeutic classes, alone or in combination.

On February 29, 2016 NewLink Genetics Corporation (NASDAQ:NLNK), a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates, including both cellular immunotherapy and checkpoint inhibitor programs, to improve the lives of patients with cancer, reported business highlights and consolidated financial results for the fourth quarter and year ended 2015. NewLink Genetics also outlined key 2016 business priorities related to the clinical development programs for the company’s immuno-oncology pipeline (Press release, NewLink Genetics, FEB 29, 2016, View Source [SID:1234509269]).

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"During 2015, we made advances across multiple immuno-oncology clinical programs," said Charles J. Link, Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific Officer. "In 2016, we look forward to reporting top-line results of algenpantucel-L in the IMPRESS trial for patients with resected pancreatic cancer as well as fundamental validation of our IDO pathway inhibitor programs."

2015 Highlights

Reported continued progress of the pivotal, Phase 3 IMmunotherapy for Pancreatic RESectable cancer Study (IMPRESS) trial of algenpantucel-L, for patients with resected pancreatic cancer.

Attracted top biotechnology talent to support increasing manufacturing capacities, the pre-commercialization efforts related to algenpantucel-L, and the expansion of clinical trial programs.

Completed enrollment in the Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced Non-Resectable Cancer (PILLAR) trial of algenpantucel-L for patients with locally advanced pancreatic cancer.

Presented Phase 1b/2 clinical data of indoximod in combination with temozolomide for patients with refractory malignant brain tumors at the Society of Neuro-Oncology Meeting, demonstrating evidence of clinical activity.

Completed enrollment in a randomized, Phase 2 trial with indoximod for patients with metastatic breast cancer and presented preliminary safety data at the San Antonio Breast Cancer Symposium.

Presented with Genentech, a member of the Roche Group, results from a Phase 1 study of GDC-0919 at ESMO (Free ESMO Whitepaper)/ECC. In addition, a Phase 1b, open-label, dose-escalation study of the safety and pharmacology of GDC-0919 in combination with atezolizumab for patients with advanced solid tumors began enrollment.

Added additional commercial oncology and clinical expertise to the board with the appointment of Mr. Paolo Pucci and Dr. Nicholas Vahanian.

Analysis of interim data from a Phase 3 ring vaccination trial in Guinea was published in the July 31st issue of The Lancet. NewLink Genetics was awarded an additional $30.5 million in government funding to support the scale-up of manufacturing for the Ebola vaccine candidate, rVSV-ZEBOV, and other vaccine development initiatives.

Finished 2015 with $197.8 million in cash and equivalents.

"In 2016, we anticipate significant progress toward milestones in our HyperAcute Cellular Immunotherapy and IDO pathway inhibitor programs," said Nicholas Vahanian, M.D., President and Chief Medical Officer. "We are building an experienced oncology commercial team in anticipation of filing, registration, and product launch of algenpantucel-L. If approved, algenpantucel-L would be the first FDA-approved drug for patients with resected pancreatic cancer."

Anticipated Highlights in 2016

Top-line results of the pivotal, Phase 3 registration IMPRESS study for patients with resected pancreatic cancer expected this year.

Update on the timing of results in the PILLAR study for patients with locally advanced pancreatic cancer.

Report on additional clinical progress from the proprietary indoximod program in multiple indications in the following Phase 2 trials:

Indoximod and gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer.

Indoximod and ipilimumab or PD-1 inhibitors for patients with metastatic melanoma.

Indoximod and temozolomide for patients with refractory malignant brain tumors.

Indoximod and docetaxel or paclitaxel for patients with metastatic breast cancer.

Accelerate enrollment in a triple combination trial of tergenpumatucel-L, indoximod and docetaxel for patients with advanced non-small cell lung cancer.

Update on the clinical progress of GDC-0919 combinations for patients with solid tumors by Genentech.

Update on progress and funding for the Zika vaccine program.

"The investments we made in 2015 advanced our pipeline of drug candidates, expanded our manufacturing capacity, and developed our pre-commercial sales and marketing infrastructure," said Jack Henneman, Executive Vice President and Chief Financial Officer. "NewLink Genetics enters 2016 in strong financial condition, positioned to support its strategic objectives of launching its lead product candidate and becoming a commercial biopharmaceutical company," added Mr. Henneman.

Financial Results

Cash Position: NewLink Genetics ended the year on December 31, 2015, with cash, cash equivalents, and certificates of deposit totaling $197.8 million compared to $202.8 million for the year ending December 31, 2014. The decrease was attributable primarily due to the increased expenses for R&D and pre-commercialization development, offset by amounts received under government contracts and the $20.0 million milestone payment from Merck in February 2015. The Company’s cash position is sufficient to fund current operations in the near and medium term.

R&D Expenses: Research and development expenses were $14.8 million and $71.4 million in the fourth quarter and year ended December 31, 2015 compared to $11.9 million and $35.7 million during the comparable periods in 2014. The increase is primarily due to clinical trial expenses related to NewLink Genetics’ broad pipeline of product candidates, as well as expenses for manufacturing and research related to the Ebola vaccine candidate. The majority of the Ebola-related expenses are subject to reimbursement under government contracts.

G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2015 were $7.7 million and $30.7 million compared to $8.3 million and $19.3 million during the comparable periods in 2014. The decrease from the quarter ended December 31, 2014 was primarily attributable to higher legal and consulting fees incurred in the fourth quarter of 2014 as compared to the fourth quarter of 2015. The increase from the year ended December 31, 2014 was primarily due to higher personnel-related costs as we prepare for potential commercialization, along with increases in share-based compensation expense, consulting and legal fees, travel expenses, and medical affairs and marketing.

Net Income/Loss: NewLink Genetics reported a net loss of $21.6 million or a $0.75 loss per diluted share for the fourth quarter of 2015 and a net loss of $40.4 million or a $1.41 loss per diluted share for the year ended December 31, 2015, compared to net income of $120.0 million or $3.83 earnings per diluted share for the fourth quarter of 2014 and net income of $96.0 million or $3.09 earnings per diluted share for the year ended December 31, 2014.

NewLink Genetics ended 2015 with 28,814,142 shares outstanding.

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations." To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 46732006. The replay will be available for two weeks from the date of the call.

HyperAcute Cellular Immunotherapies

A unique, tumor-specific product candidates that take advantage of a pre-existing human immune response to initiate a powerful cascade, potentially educating the body’s natural defenses to identify and destroy cancer cells. Unlike other immuno-oncology products, HyperAcute Cellular Immunotherapies do not require patient tissue or cancer cells and are designed to be easy to administer. HyperAcute Cellular Immunotherapies use allogeneic (disease-specific, not patient-specific), tumor-specific human cell lines that have been modified to express alpha-gal. Intact, whole cells are used rather than cell fragments or purified proteins, which we believe results in the stimulation of a more powerful immune response. The company’s most advanced clinical program utilizing this technology is for patients with pancreatic cancer. Additionally, there are on-going clinical development programs and data on induced immune responses targeting non-small-cell lung cancer, melanoma, prostate cancer and renal cancer.

Indoleamine 2,3-Dioxygenase (IDO) Checkpoint Inhibitors

The indoleamine 2,3-dioxygenase (IDO) pathway regulates immune response by suppressing T cell function and enabling local tumor immune escape. NewLink Genetics is researching two IDO pathway inhibitors, GDC-0919 (in partnership with Genentech) and indoximod, both small-molecule product candidates that have the potential to disrupt mechanisms by which tumors evade the immune system. NewLink Genetics’ indoximod and GDC-0919 each have a distinct mechanism of action within the IDO pathway and are in Phase 1 and 2 clinical trials for a range of cancers, including breast cancer, melanoma, and other solid tumors.

Ebola Vaccine Program with Merck

NewLink Genetics is also working to address infectious diseases, such as Ebola and Zika. The Ebola vaccine candidate rVSV-ZEBOV (licensed to Merck & Co.) received the Best Prophylactic Vaccine award at the 15th Annual World Vaccine Congress on April 8, 2015, in Washington, DC. Interim results of a study in Guinea featured in the July issue of The Lancet showed potential efficacy with potential for both pre- and post-exposure use. NewLink Genetics and Merck received the Best Vaccine License award, which recognizes the business partnership with the greatest potential for success in bringing innovative medicines to market. rVSV-ZEBOV was originally developed by the Public Health Agency of Canada and was subsequently licensed to a wholly-owned subsidiary of NewLink Genetics.

On February 29, 2016 PharmaMar reported its Full Year 2015 financial results. The Group’s revenues totalled €193.8 million in 2015, the highest ever top-line reading and an increase of 11% with respect to 2014 (Press release, PharmaMar, FEB 29, 2016, View Source [SID:1234509271]). This figure was boosted by 15% growth in net sales of Yondelis, to €88.4 million in 2015, the best year for Yondelis sales since the drug was approved in 2007. Overall, the group’s biopharmaceutical area ended 2015 with €94.6 million in net sales, a 15% year-on-year increase.

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Net sales in the consumer chemicals segment also expanded, by 3% to €67.3 million, in 2015.

Other revenues, which include licence fees, royalties and other service charges, amounted to €31.8 million in 2015, an 18% increase with respect to 2014.

Research and development expenditure increased by 21% in 2015 to €63.5 million (€52.4 million in 2014). R&D spending was focused mainly in oncology, principally for clinical development of PM1183. PharmaMar is currently conducting pre-clinical and clinical trials with this molecule in a number of solid tumour indications, including a Phase III registration trial in platinum-resistant ovarian cancer, recruitment for which commenced in the second half of the 2015. The company also plans to start another pivotal Phase III trial with PM1183 in 2016 in the treatment of small-cell lung cancer (SCLC).

As a result, PharmaMar group EBITDA amounted to €19.4 million in 2015 (vs. €25.7 million in 2014) and net profit amounted to €6.5 million (€13 million in 2014). 2 During the year, the Company refinanced over €30 million of short-term debt, which improved its debt structure and released funds to continue investing in R&D. At 31 December 2015, net debt amounted to €46.9 million, compared with €54.8 million at the end of 2014.