On November 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the third quarter ended September 30, 2015 (Press release, Momenta Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507948]).

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For the third quarter of 2015, the Company reported total revenues of $13.8 million, including $8.7 million of GlatopaTM (glatiramer acetate injection) profit share. For the nine months ended September 30, 2015, the Company reported total revenues of $67.3 million, including $27.9 million in product revenues from Sandoz’s sales of Glatopa. Momenta reported a net loss of $(30.1) million, or $(0.44) per share for the third quarter compared to a net loss of $(29.1) million, or $(0.56) per share for the same period in 2014. For the nine months ended September 30, 2015, the Company reported a net loss of $(54.1) million, or $(0.88) per share compared to a net loss of $(82.6) million, or $(1.61) per share for the same period in 2014. At September 30, 2015, the Company had cash, cash equivalents, and marketable securities of $374.9 million.

"The launch of Glatopa is going according to plan with Glatopa scripts currently representing approximately 25% to 30% of the once daily glatiramer acetate market," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "As the first marketed generic version of a multiple sclerosis drug, Glatopa is bringing value to both patients and payors."

"We continue to advance our biosimilar and novel drug programs. Our Phase 2 study of necuparanib in pancreatic cancer is advancing and M923, our biosimilar HUMIRA candidate, has entered a pivotal clinical trial," continued Mr. Wheeler. "Our ongoing development activities should also allow us to move M834, our biosimilar ORENCIA candidate, and our two novel recombinant autoimmune candidates into the clinic in 2016."

Third Quarter Highlights and Recent Events

Complex Generics:
GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

Sandoz launched Glatopa on June 18, 2015. In the third quarter of 2015, Momenta recorded $8.7 million in product revenues from Sandoz’s Glatopa sales. Glatopa is experiencing positive trade uptake, although the impact on third quarter sales was limited as launch inventory continues to be worked through. In the second quarter of 2015 Momenta’s share of profit on sales of Glatopa was $28.2 million, and after a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses, the Company recorded $19.2 million in product revenue.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz, is under FDA review.

Enoxaparin Sodium Injection

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Actavis. In July 2015, the U.S. Solicitor General, at the request of the Court of Appeals for the Federal Circuit, filed a brief in the case that supported Momenta’s interpretation of the scope of the "safe harbor" provisions under the Hatch Waxman Act. A CAFC decision is expected in 2015.

Biosimilars:

In October 2015, Momenta and Baxalta announced the initiation of a pivotal clinical trial for M923, a biosimilar version of HUMIRA (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018.
Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential partners to collaborate on the development and commercialization of a portfolio of its biosimilar candidates.

Novel Drug:
Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is enrolling. The Company expects to have clinical data available in the first half of 2017.
The Company continues to collect data from the Phase 1 study and plans to publish and/or present updated results following completion of the study.

Autoimmune Drugs
Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Third Quarter 2015 Financial Results

Total revenues for the third quarter of 2015 were $13.8 million compared to $9.3 million for the same period in 2014. Total revenues for the third quarter of 2015 includes $8.7 million in product revenue, which represents 50% of contractual profit earned from Sandoz’s sale of Glatopa.

Enoxaparin product revenue decreased from $4.7 million for the third quarter of 2014 to zero for the same period in 2015. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. In the third quarter of 2015, Sandoz did not earn a profit on its sales of enoxaparin due to continued competitive pricing.

Collaborative research and development revenue for the third quarter of 2015 was $5.1 million, compared to the $4.6 million recorded in the same quarter last year. The increase is primarily due to an increase in the quarterly amortization of the upfront payment under the Baxalta collaboration.

Research and development expenses for the third quarter of 2015 were $31.7 million, compared to $27.5 million for the same period in 2014. The increase of $4.2 million, or 15%, from the 2014 period primarily resulted from increases of $2.0 million in nonclinical and manufacturing expenditures to advance the novel autoimmune programs, $1.8 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients and $0.3 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended September 30, 2015, were $12.5 million, compared with $11.1 million for the same period in 2014. The increase of $1.4 million, or 13%, from the 2014 period primarily resulted from increases of $0.8 million in share-based compensation associated with performance-based stock awards and $0.3 million in professional fees.

At September 30, 2015, Momenta had $374.9 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

Financial Guidance
Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $40 – $42 million per quarter for the fourth quarter of 2015.

On November 4, 2015 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, reported findings that support the potential of ATLAS, the Company’s proprietary rapid antigen identification screening system, to profile responses to immunotherapies for cancer (Press release, Genocea Biosciences, NOV 4, 2015, View Source [SID:1234507945]). This analysis, in which ATLAS identified the specificity and characteristics of T cell responses in cancer patients, will be presented as a late-breaker at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #342, entitled Immunoprofiling of T cell responses in melanoma patients undergoing CPI therapy, will be presented on Saturday, November 7, 2015 between 12:00 – 2:00 p.m. ET.

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In this pilot study, funded by the Ludwig Trust, Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct a retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients’ T cell responses to 23 known tumor-associated antigens. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as "decoys," further validating the ability of ATLAS to distinguish clinically relevant targets of T cell responses.

"The breakthroughs we’ve seen in the immuno-oncology field to date have been profound, yet emerging treatment approaches do not yet include an understanding of who may respond to therapy and why," said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. "These findings provide strong proof of concept that ATLAS can take a panoramic view of a large, diverse population of cancer patients and reveal clinically relevant signatures of protective responses. We believe we are uniquely positioned to utilize our technology to enable smarter profiling – indicating what must be present to see a benefit from therapy – as well as smarter identification of T cell antigens to drive cancer vaccine development."

The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.

About ATLAS

ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.

On November 4, 2015 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, reported that it will present data from 11 accepted abstracts on the role of histone methyltransferase (HMT) inhibition in human cancers at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place in Boston, Mass., November 5 – 9, 2015 (Press release, Epizyme, NOV 4, 2015, View Source [SID:1234507944]). Among the presentations are important new data on the critical role played by EZH2 in Non-Hodgkin Lymphoma (NHL). Epizyme’s lead compound, tazemetostat, is a first-in-class EZH2 inhibitor currently being studied in relapsed or refractory B-cell NHL and advanced solid tumors.

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"Epizyme is leading the field of epigenetic drug discovery with our focused approach to development of small molecule therapeutics against HMTs and other chromatin modifiers," said Robert A. Copeland, Ph.D., President of Research and Chief Scientific Officer. "Our presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting demonstrate the breadth of our drug discovery efforts and preclinical target identification in this space and our continued commitment to understanding the role of EZH2 and EZH2 inhibition across a spectrum of cancer indications."

Presentations on the role of EZH2 include:

EZH2 Plays a Critical Role in B-cell Maturation and in Non-Hodgkin Lymphoma: Interplay between EZH2 Function and B-cell Activation
Abstract number: B85
Speaker: Danielle Johnston, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Advanced Image Analysis of H3K27 Trimethylation in Skin from Subjects Dosed with the EZH2 Inhibitor Tazemetostat
Abstract number: B6
Speaker: Alice McDonald, Epizyme, Inc.
Session title: Poster Session B, Biomarkers
Presentation time: Saturday, November 7, 12:30 – 3:30

EZH2 Inhibition Leads to Decreased Proliferation in SMARCA4-deleted Ovarian Cancer Cell Lines
Abstract number: C87
Speaker: Elayne Penebre, Epizyme, Inc.
Session title: Poster Session C, Epigenetic Targets
Presentation time: Sunday, November 8, 12:30 – 3:30

Initial Testing (Stage 1) of EPZ-6438 (tazemetostat), a Novel EZH2 Inhibitor, by the Pediatric Preclinical Testing Program (PPTP)
Abstract number: A137
Speaker: Raushan Kurmasheva, Greehey Children’s Cancer Research Institute
Session title: Poster Session A, Pediatric Early Drug Development
Presentation time: Friday, November 6, 12:15 – 3:15

Physiologically-based pharmacokinetic modeling to support clinical investigation of the EZH2 inhibitor, tazemetostat (EPZ-6438) in INI1-deficient pediatric tumors
Abstract number: A135
Speaker: Nigel Waters, Epizyme, Inc.
Session title: Poster Session A, Pediatric Early Drug Development
Presentation time: Friday, November 6, 12:15 – 3:15

Chromatin Flow Cytometry Based Quantification of Cell Type Specific Alterations in Histone Methylation States Resulting from in vitro and in vivo EZH2 Inhibitor Treatment
Abstract number: B133
Speaker: Christopher Plescia, Epizyme, Inc.
Session title: Poster Session B, Novel Assay Technology
Presentation time: Saturday, November 7, 12:30 – 3:30

In addition to these presentations on the role of EZH2, Epizyme will present additional data on the company’s ongoing work to elucidate the potential of HMT inhibitors as treatments for human cancers. These additional presentations include:

CRISPR Pooled Screening Identifies Differential Dependencies on Epigenetic Pathways
Abstract number: B78
Speaker: Alexandra R. Grassian, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Pinometostat (EPZ-5676) Enhances the Anti-proliferative Activity of MAP Kinase Pathway Inhibitors in MLL-r Leukemia Cell Lines
Abstract number: B82
Speaker: Alejandra Raimondi, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Identification of a Novel Potent Selective SMYD3 Inhibitor with Oral Bioavailability
Abstract number: C85
Speaker: Lorna Mitchell, Epizyme, Inc.
Session title: Poster Session C, Epigenetic Targets
Presentation time: Sunday, November 8, 12:30 – 3:30

Identification of Biomarkers and Pathways Associated with Response to the DOT1L Inhibitor Pinometostat (EPZ-5676) in MLL-r Leukemia
Abstract number: C12
Speaker: Scott Daigle, Epizyme, Inc.
Session title: Poster Session C, Biomarkers
Presentation time: Sunday, November 8, 12:30 – 3:30

A Medium-Throughput Single Cell CRISPR CAS9 Assay to Assess Gene Essentiality
Abstract number: C162
Speaker: Alexandra Grassian, Epizyme, Inc.
Session title: Poster Session C, Target Identification and Validation
Presentation time: Sunday, November 8, 12:30 – 3:30

About EZH2 in Cancer

EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include Non-Hodgkin Lymphoma, INI1-deficient cancers such as malignant rhabdoid tumors, epithelioid sarcomas and synovial sarcoma, and a range of other solid tumors.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with Non-Hodgkin Lymphoma and for patients with INI1-deficient solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about this program, including clinical trial information, may be found here: View Source

On November 4, 2015 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported that two abstracts from the Company’s immuno-oncology programs have been selected for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held November 5-9, 2015 in Boston, Massachusetts (Press release, ChemoCentryx, NOV 4, 2015, View Source [SID:1234507942]). The abstracts highlight clinical stage results in a pancreatic cancer trial with CCX872, the Company’s second inhibitor of the chemokine receptor known as CCR2, and, separately, preclinical results in a model of triple negative breast cancer using combination therapy employing an antibody against the checkpoint inhibitor PD-L1 in conjunction with CCX9588, an inhibitor of the chemokine receptor known as CCR1.

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"Tumors have devised ways to suppress anti-tumor immune responses in part by importing immune suppressor cells into the tumor microenvironment. One goal of our chemoattractant based immuno-oncology program is to develop treatments that specifically reduce the content of immune suppressive elements in the tumor mass, thus enabling the body’s effector immune response to predominate," said Thomas J. Schall, Ph.D., President and Chief Executive Officer. "Towards this end, in our pancreatic cancer trial we are encouraged by observations to date of excellent coverage of the receptor CCR2, which guides suppressor cells to the tumor, by our drug CCX872, and we except to see greater than 90 percent receptor coverage continuously in the ongoing multi-dose portion of the study. Patient recruitment in the trial is ramping up, having reached 20 percent of the target enrollment, and we look forward to efficacy data from this trial in 2016. Also, our preclinical model work using a combination of checkpoint inhibitor antibody therapy in combination with an orally administered chemokine receptor inhibitor may pave the way for new treatment options in such important areas as triple negative breast cancer."

Part A Results of Pancreatic Cancer Clinical Trial for CCX872

Pharmacokinetic and pharmacodynamic profile of the novel, oral and selective CCR2 inhibitor CCX872-B in a Phase Ib pancreatic cancer trial, Hezel et al, (Abstract #B24, poster presentation November 7 from 12:30-3:30 p.m. ET, Session B, Hall C-D)

In the ongoing clinical trial in patients with pancreatic cancer with the Company’s CCR2 inhibitor, CCX872, all patients are receiving FOLFIRINOX and CCX872. The two-part trial includes Part A, in which patients receive a single dose of CCX872, and Part B, in which patients receive once or twice daily doses of CCX872 initially for 12 weeks with the ability to continue treatment unless disease progression or unacceptable intolerability occurs. In the trial, the Company plans to evaluate CCX872 in up to 54 patients. The primary efficacy measurement is progression-free survival when patients have completed at least 24 weeks of treatment.

From the abstract, after a single dose of CCX872, across four patients in Part A, the pharmacokinetic profile was favorable and pharmacodynamic assays demonstrated excellent receptor coverage after 12 hours. With 4 to 5-fold accumulation of plasma concentrations with twice daily dosing in Part B, the authors expect to see greater than 90 percent coverage of the receptor throughout the day.

Preclinical Data of Combination Therapy of Chemokine Receptor and Checkpoint Inhibitors

Combination therapy of chemokine receptor inhibition plus PD-L1 blockade potentiates anti-tumor effects in a murine model of breast cancer, Jung et al, (Abstract #A90, poster presentation November 6 from 12:15-3:15 p.m. ET, Session A, Hall C-D)

The Company’s immuno-oncology program is pursuing a better understanding of the body’s immune response to tumors and is therefore conducting studies with various chemokine receptor inhibitors in combination with checkpoint inhibitors that may result in beneficial anti-tumor effects. Results from a study of one of the Company’s inhibitors of the chemokine receptor known as CCR1, CCX9588, demonstrated the ability to act synergistically with a PD-L1 inhibitor to reduce tumor burden in a preclinical model of triple negative breast cancer.

From the abstract, CCX9588, when delivered in combination with an anti-PDL1 antibody, resulted in significantly reduced primary tumor growth and lung metastasis, as compared to either agent alone. In addition, an analysis of tumor-infiltrating cells revealed that the addition of CCX9588 to the anti-PD-L1 antibody significantly reduced the number of myeloid derived suppressor cells (MDSCs) in primary tumors, potentially contributing to the overall reduction of tumor burden. These preclinical results were also accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held from November 4-8, in National Harbor, MD.

"One of the most exciting advances in oncology in decades is the recent observation that modifiers of the activity of the body’s own immune system can profoundly enhance the response to chemotherapy," said Israel F. Charo, M.D., Ph.D., Senior Vice President, Research, ChemoCentryx. "We believe that chemokine receptor inhibitors such as CCX9588, combined with immunotherapy or traditional chemotherapy, may result in greater efficacy and fewer systemic side effects."

About the ChemoCentryx Immuno-Oncology Program

CCR1- and CCR2-bearing cells, such as myeloid derived suppressor cells (MDSCs), are thought to possess an immunosuppressive behavior. MDSCs effectively help tumors hide from the body’s natural cytotoxic immune response to tumor cells. Inhibiting CCR1 and CCR2, may lead to the liberation of the cytotoxic immune response against tumor cells, reduced tumor burden and potentially lead to improved patient survival.

The Company currently has an ongoing clinical trial of CCX872, an inhibitor of the chemokine receptor known as CCR2, in patients with non-resectable pancreatic cancer. In addition, the Company is conducting preclinical research with various chemokine receptor inhibitors in combination with checkpoint inhibitors, such as those inhibiting the PD-L1 pathway, which may result in a greater anti-tumor effect than with checkpoint inhibition alone. CCX9588 is a small molecule inhibitor of CCR1 and is currently in preclinical development for certain oncology indications targeting both solid and liquid tumors.

On November 4, 2015 Array BioPharma Inc. (NASDAQ: ARRY) reported results for the first quarter of its fiscal year ending June 30, 2016 and provided an update on progress on its key clinical development programs (Press release, Array BioPharma, NOV 4, 2015, View Source;p=RssLanding&cat=news&id=2106469 [SID:1234507941]).

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Ron Squarer, Chief Executive Officer of Array, noted, "The first quarter has been a period of important progress as we continue to advance binimetinib and encorafenib, two innovative oncology products in Phase 3, toward 2016 regulatory submissions. Recently presented data supports the value of our BRAF-mutant melanoma and BRAF-mutant colorectal cancer programs by showing the potential for differentiation compared to other approaches."

KEY PIPELINE UPDATES

Binimetinib (MEK162) and encorafenib (LGX818)

NEMO (binimetinib / NRAS-mutant melanoma) and COLUMBUS Part 1 and Part 2 (binimetinib and encorafenib / BRAF-mutant melanoma) target enrollment achieved
NEMO and COLUMBUS top-line results expected in 2H 2015 and 1H 2016, respectively
BRAF- and NRAS-melanoma trial results presented at ESMO (Free ESMO Whitepaper) European Cancer Congress (ECC)

Update on Phase 3 trials

In April 2015, the NEMO Phase 3 study completed patient enrollment and Array expects top-line results by year end and a regulatory filing in the first half of 2016. In addition, the COLUMBUS (Part 1) study also completed enrollment in April 2015 and Array expects top-line results and reaffirms a projected regulatory filing of binimetinib and encorafenib in 2016. In October 2015, COLUMBUS (Part 2) achieved its target patient enrollment. The MILO Phase 3 trial in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates the availability of top-line data from MILO, along with a projected regulatory filing, in 2017.

New BRAF-mutant melanoma interim results

LOGIC2 is an ongoing 140-patient, two-part study designed to explore the safety and activity of novel triplet combinations in BRAF-mutant melanoma. In Part 1, patients are treated with the combination of binimetinib and encorafenib until disease progression. Based on the results of molecular profiling at that time, each patient is assigned to one of four arms containing a triplet combination of binimetinib, encorafenib and a third innovative targeted therapy. Results from Part 1 of the study were reported separately for patients who have previously received a BRAF and/or MEK inhibitor versus those who were initially naïve to BRAF and MEK inhibitor treatment.

In Part 1, patients are treated with binimetinib 45 mg twice daily (BID) and encorafenib 450 mg once daily (QD), the same doses evaluated in the ongoing Phase 3 COLUMBUS trial. Interim results from this study were presented at ESMO (Free ESMO Whitepaper) ECC in September 2015. In the BRAF/MEK-naïve group (n=40), the interim overall response rate (confirmed and unconfirmed complete response or partial response) was 68%, with a 6-month progression-free survival estimate of 79%. Of note, 96% of patients in this group continued to receive study treatment as of the data cutoff. Preliminary data from all patients in the study (n=89) also indicate that the combination of binimetinib and encorafenib showed good tolerability with a 12% incidence of pyrexia and little to no rash or photosensitivity. These results indicate that the combination of binimetinib and encorafenib show encouraging clinical activity and an emerging differentiated tolerability profile relative to other MEK/BRAF inhibitor combinations.

New NRAS-mutant melanoma interim results

Promising preliminary antitumor activity from a Phase 1b/2 study of binimetinib in combination with ribociclib (Novartis, LEE011), a CDK4/6 inhibitor, in NRAS-mutant melanoma patients, was presented at ESMO (Free ESMO Whitepaper) ECC. Results were shared from 45 patients enrolled in the dose escalation portion of the study, which included two dosing schedules (28-day or 21-day cycles). For the 28-day dosing schedule, patients received continuous twice daily dosing of binimetinib while receiving ribociclib for 21 days per 28 day cycle. For the 21-day schedule, both agents were delivered for 14 days of a 21 day cycle.

For patients receiving the combination on a 28-day cycle (n=22), the Objective Response Rate (ORR, confirmed and unconfirmed complete or partial responses) was 41%, the Disease Control Rate (DCR, confirmed and unconfirmed complete or partial responses and stable disease) was 82% with a median Progression Free Survival (mPFS) of 6.7 months. Furthermore, the ORR was 56% (n=9) for patients receiving dose level 1 of the 28-day schedule consisting of binimetinib 45 mg BID and the lowest dose of ribociclib (200 mg QD), indicating that robust activity can be achieved with this dose and schedule. Common treatment-related adverse events included elevated creatine phosphokinase (CPK), skin and gastrointestinal events. Investigation of the alternative 21-day schedule is ongoing.

Update on European partnership

Array expects to complete a European partnership for both binimetinib and encorafenib by year end and will provide further updates as appropriate.

Selumetinib (partnered with AstraZeneca) – Three registration trials advancing in NSCLC (SELECT-1), thyroid cancer (ASTRA) and neurofibromatosis type 1

AstraZeneca continues to advance selumetinib in three registration trials: SELECT-1 in patients with KRAS-mutant non-small cell lung cancer, a registration trial in patients with neurofibromatosis type 1 and ASTRA in patients with differentiated thyroid cancer. AstraZeneca expects to share top-line results from SELECT-1 in 2016.

ARRY-797 (ARRY-371797) – Phase 2 trial on-going in patients with LMNA A/C-related dilated cardiomyopathy (DCM)

Array is conducting a 12-patient Phase 2 study to evaluate the effectiveness and safety of ARRY-797 in patients with LMNA A/C-related DCM, a serious, genetic cardiovascular disease. By age 45, approximately 70% of patients with LMNA A/C-related DCM experience cardiovascular death, transplant or a major cardiac event. Currently, Array has patients on this trial past 48 weeks and ARRY-797 has been well-tolerated. Patients completing this Phase 2 trial are being enrolled in a roll-over study to continue treatment. Interim data continue to be encouraging for multiple endpoints across patients, but further data are needed to fully assess the magnitude, consistency and durability of effects.

Filanesib (ARRY-520) – Two Phase 2 studies nearing completion; No current plans to initiate additional clinical trials with filanesib

Given Array’s significant opportunity with the Phase 3 binimetinib and encorafenib programs across a number of cancer indications, Array currently has no plans to initiate additional trials with filanesib, a highly selective, targeted KSP inhibitor. Two studies in patients with relapsed / refractory multiple myeloma are nearing completion: a randomized Phase 2 trial of the combination of filanesib and Kyprolis (carfilzomib) and Kyprolis alone (ARRAY-520-216) and the AfFIRM trial, a Phase 2 single agent study. Array expects to present interim data from the ARRAY-520-216 study at a scientific conference by the end of the year.

LEADERSHIP

Array appoints Patricia Henahan to Chief Financial Officer

Array appointed Patricia Henahan to the position of Chief Financial Officer. Ms. Henahan has extensive financial experience in the biopharmaceutical industry including leadership roles at Hospira, AstraZeneca, Eli Lilly and MedImmune. She has strong expertise in strategic planning, financial analysis, commercialization, R&D, operations and alliance management. Prior to joining Array, Ms. Henahan was Vice President of Finance for Hospira’s $3 billion U.S. pharmaceutical-focused business. During her tenure, Hospira delivered double-digit profit growth and achieved its highest ever U.S. market share and revenue level.

FINANCIAL HIGHLIGHTS

Cash, cash equivalents, marketable securities and accounts receivable totaled $173.3 million at the end of the quarter. Accounts receivable primarily consist of receivables expected to be paid by Novartis within three months. In March 2015, two clinical programs, binimetinib and encorafenib, became wholly-owned assets which prompted changes to our classification of revenue and expenses for the programs. The new expense classifications were included in the fourth quarter of fiscal 2015 financial results and, beginning in the current quarter, Array reports revenue from Novartis reimbursements as a separate line item called "reimbursement revenue."

First Quarter of Fiscal 2016 Compared to Fourth Quarter of Fiscal 2015 (Sequential Quarters Comparison)

Revenue for the first quarter of fiscal 2016 was $16.2 million, compared to $12.3 million for the prior sequential quarter. The $3.9 million increase in revenue was primarily due to higher reimbursement revenue from Novartis. Cost of partnered programs for the first quarter of fiscal 2016 was $6.2 million, compared to $7.0 million for the prior quarter. Research and development expense was $21.0 million, compared to $18.6 million in the prior quarter. The increase in research and development expense is primarily related to the ongoing transition of binimetinib and encorafenib trials from Novartis to Array. Net loss for the first quarter was $21.0 million, or ($0.15) per share, and was $12.7 million, or ($0.09) per share in the prior quarter as the fourth quarter of fiscal 2015 was favorably impacted by a $11.5 million in gains from the sale of marketable securities and our CMC business.

First Quarter of Fiscal 2016 Compared to First Quarter of Fiscal 2015 (Prior Year Comparison)

Compared to the same quarter of fiscal 2015, revenue for the first quarter of fiscal 2016 increased $10.1 million primarily due to $9.6 million in reimbursement revenue from Novartis. Cost of partnered programs decreased $6.0 million compared to the first quarter of fiscal 2015 primarily due to binimetinib development costs being presented as research and development expense instead of cost of partnered programs upon becoming wholly-owned programs. Research and development expense increased $8.8 million compared to the first quarter of fiscal 2015 due to the categorization of binimetinib costs, as well as new spending on encorafenib, which was not an Array asset in the prior year period. Net loss for the first quarter of fiscal 2016 was $21.0 million, or ($0.15) per share, and was $27.6 million, or ($0.21) per share, for the same quarter in fiscal 2015.

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