On November 5, 2015 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for its quarter ended September 30, 2015, and provided an update on the Company’s clinical development programs for 2015 (Press release, Clovis Oncology, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107598 [SID:1234508032]).

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"We are entering a new phase at Clovis, transitioning into becoming a commercial biopharmaceutical company," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Our U.S. commercial organization, including the sales force, is now fully in place. This team is highly experienced, enthusiastic and ready to go, following our U.S. launch meeting last week. We are now fully prepared to launch rociletinib upon a potential U.S. approval and we are actively building our E.U. commercial organization in preparation for a late 2016 launch in Europe. Additionally, having advanced our rucaparib NDA submission timeline to Q2 2016, we are planning for a potential U.S. launch of rucaparib for advanced ovarian cancer by the end of 2016. We are very enthusiastic about the prospect of having our commercial organization support sales for both rociletinib and rucaparib."

Third Quarter 2015 Financial Results

Net loss attributable to common shareholders was $98.6 million ($2.62 per share) for the third quarter of 2015 and $233.3 million ($6.62 per share) for the first nine months of 2015, compared to a net loss of $39.6 million ($1.17 per share) and $105.1 million ($3.10 per share) for the comparable periods of 2014.

Research and development expenses totaled $76.1 million for the third quarter of 2015 and $193.3 million for the first nine months of 2015, compared to $35.0 million and $87.6 million for the comparable periods in 2014. The increase in expenses for both the three- and nine-month periods is due to the significantly expanded clinical development activities for rociletinib and rucaparib, increased launch planning activities for rociletinib and increased personnel-related expenses associated with the hiring of additional staff to support the Company’s expanded activities.

General and administrative expenses totaled $8.3 million for the third quarter of 2015 and $22.3 million for the first nine months of 2015, compared to $5.3 million and $15.9 million for the comparable periods in 2014. The year over year increase is primarily due to higher share-based compensation and personnel expense for employees engaged in general and administrative activities, increased facility costs and higher professional service fees.

Acquired in-process research and development expenses totaled $12.0 million for both the third quarter of 2015 and the first nine months of 2015. There was no acquired in-process research and development expense for the third quarter of 2014 and $8.8 million for the first nine months of 2014. During the third quarter of 2015, the Company made milestone payments totaling $12.0 million to Celgene Corporation upon acceptance of the NDA and MAA submissions for rociletinib by the FDA and EMA, respectively.

Share-based compensation expense totaled $12.4 million for the third quarter of 2015 and $29.5 million for the first nine months of 2015.

Clovis had $605.9 million in cash, cash equivalents and available-for-sale securities and approximately 38.3 million outstanding shares of common stock as of September 30, 2015. Our net cash used in operations for the third quarter of 2015 was $71.7 million and $177.4 million for the first nine months of 2015, including $12.0 million in rociletinib milestone payments. In July 2015, the Company raised net proceeds of $298.5 million through an offering of 4.1 million shares of common stock.

2015 Key Milestones and Objectives

Highlights of planned or completed objectives for each product follows:

Rociletinib

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for rociletinib and has granted it priority review status with a Prescription Drug User Fee Act (PDUFA) action date of March 30, 2016. In addition, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for rociletinib.

The U.S. commercial and medical affairs organizations are now in place and efforts are currently underway to build out the E.U. commercial organization.

Rociletinib was the subject of several posters and presentations during the third quarter, including updates of data from the TIGER-X study in EGFR mutant, T790M-positive patients with a history of CNS involvement, as well as EGFR mutant, T790M-negative patients as determined by tissue as well as plasma testing. Posters and presentations for all Clovis products in development presented during the third quarter may be viewed at View Source

Rucaparib

During the third quarter, updated findings from ARIEL2 and Study 10, two ongoing studies evaluating the safety and activity of rucaparib in advanced ovarian cancer patients were presented at the 18th ECCO – 40th ESMO (Free ESMO Whitepaper) European Cancer Congress. Data from these studies demonstrated encouraging activity and safety in women with advanced, platinum-sensitive ovarian cancer with tissue BRCA (gBRCA and sBRCA) mutations. In addition, these data demonstrated that the application of Clovis’ proprietary BRCA-like tumor DNA signature to Foundation Medicine’s companion diagnostic assay successfully predicts the population of BRCA-like patients that are not gBRCA or sBRCA that respond to rucaparib therapy. Highlights of the data presented included the following (all response rates RECIST):

Data from ARIEL2 in 40 evaluable BRCA-mutant patients demonstrated an ORR of 75%, a median PFS of 12.8 months and a median duration of response of 9.5 months
Complete responses (CRs) observed in 15% of patients
Data from ARIEL2 in 77 evaluable patients with the BRCA-like signature demonstrated an ORR of 36%, a median PFS of 5.7 months and a median duration of response of 8.2 months
Data from Study 10 in 39 evaluable germline BRCA-mutant patients demonstrated an ORR of 67%, a disease control rate (DCR) of 87%, and median duration of response of 6.6 months
CRs observed in 8% of patients in this group
Rucaparib is well-tolerated with a manageable safety profile; the grade 3/4 treatment-related adverse events (AEs) observed in >15% of patients treated with the recommended 600mg BID dose were anemia/decreased hemoglobin (19%) in ARIEL2, and fatigue/asthenia (21%), and anemia (26%) in Study 10
Based on these compelling data, Clovis intends to submit an NDA to the FDA for rucaparib as treatment for advanced ovarian cancer patients with a tissue BRCA mutation in the second quarter of 2016, with the intention, pending data, to follow with a supplemental NDA for advanced ovarian cancer patients with a BRCA-like mutation. During the quarter, Clovis completed enrollment of the mutant BRCA population that will serve as the basis of its planned NDA submission.

Lucitanib

A Phase 2 program is ongoing to explore lucitanib in multiple indications, including a U.S. study in patients with treatment-refractory FGF-aberrant breast cancer and a global study in patients with advanced lung cancer with FGFR1 amplification, both of which are currently enrolling patients. In parallel with these Clovis-sponsored studies, a Servier-sponsored Phase 2 study of lucitanib in patients with advanced breast cancer is underway to identify the population of patients most likely to benefit from lucitanib therapy.

Management Update

Erle Mast, Clovis’ Executive Vice President, Chief Financial Officer and Clovis co-founder, has announced his plan to retire effective March 31, 2016. The Company is initiating a search for Erle’s successor, and intends to recruit a candidate prior to his departure date to enable a transition period during the first quarter.

"With great regret we announce today that Erle Mast, Chief Financial Officer and a co-founder of Clovis, and importantly, my friend and colleague for more than 14 years, has informed us of his plans to retire on March 31, 2016," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "While I am very sorry to see him go, I certainly understand his decision and can only add how much I have enjoyed working with him and appreciate all that he has done for Clovis. Obviously, we are confident that we will be able to recruit a highly qualified individual as a new CFO and appreciate very much Erle giving sufficient notice to allow a smooth transition."

(Filing, 10-Q, Merck & Co, NOV 5, 2015, View Source [SID:1234508052])

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On November 5, 2015 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the expansion of its 3D Biology portfolio with the commercial launch of the nCounter PanCancer Profiles, seven new gene expression panels each designed to interrogate a focused area of cancer biology including immuno-oncology (Press release, NanoString Technologies, NOV 5, 2015, View Source [SID:1234507995]). The panels are focused on Adaptive Immunity, Cancer Metabolism, Intracellular Signaling, Cellular Profiling, Wnt Pathway, Innate Immunity, and DNA Damage & Repair. Each 192-gene panel includes 180 topic-specific probes and twelve universal housekeeping genes. These panels may be combined with nCounter protein expression modules to enable a deeper view of biology through simultaneous analysis of gene and protein expression in key areas of interest to cancer biologists including immuno-oncology researchers.

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"NanoString is excited to offer the power of 3D Biology technology in a series of focused PanCancer Profiles that enable our customers to measure gene and protein expression simultaneously," said Joseph M. Beechem, Ph.D., Senior Vice President of Research & Development at NanoString Technologies. "We believe the power of 3D Biology technology will drive a new frontier of immuno-oncology biomarker discovery and utilization, enabling our customers to become leaders in developing a deeper understanding of the underlying biology and its relevance to cancer immunology."

The new PanCancer Profiles leverage NanoString’s new 3D Biology technology, enabling multiplexed digital assays that provide a deeper view of biology through the analysis of multiple analytes at once. Designed for flexibility, these panels can be used as assay development building blocks and may be combined with nCounter protein assays, creating new possibilities for researchers to interrogate both protein and RNA in a single experiment. By providing a menu of focused RNA profiling options, researchers can tailor their assay to meet the needs of their experiments. For example, the 30 protein targets from the Protein Immune Profiling Panel may be added to the nCounter PanCancer Profiles Cancer Metabolism Panel to investigate how the blockade of a growth factor receptor (e.g., anti-HER2/neu) alters tumor cell metabolism while simultaneously measuring downstream activation of innate and adaptive immune cell populations in response to dying tumor cells. Also, the new panels may be customized with up to 24 additional gene expression targets defined by the user. Visit www.nanostring.com/pancancer_profiles to learn more.

At the 2015 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in National Harbor, Maryland, NanoString will be hosting a luncheon seminar entitled "Bringing the next-generation of immuno-oncology biomarkers to the clinic." Dr. Beechem will provide an introduction to NanoString’s 3D Biology technology and the new PanCancer Profiles, and Alessandra Cesano, M.D., Ph.D., Chief Medical Officer at NanoString Technologies, will moderate a panel discussion featuring presentations by key opinion leaders from academia and the pharmaceutical industry. The seminar begins Friday, November 6 at 12:30pm ET.

The new PanCancer Profiles build on the success of the company’s existing nCounter PanCancer Immune Profiling Panel for gene expression analysis and the recently introduced nCounter PanCancer RNA:Protein Immune Profiling Panel for multi-analyte analysis. Gene expression targets selected for these panels include genes which are representative of topics indicated in the Hallmarks of Cancer, first described in seminal papers by Hanahan and Weinberg (Hanahan, D., and Weinberg, R.A. (2000). Cell 100, 57-70 and Hanahan, D., and Weinberg, R.A. (2011). Cell 144, 646-674). The nCounter Protein Immune Profiling Panel measures immune cell types, cancer antigens, checkpoint blockades and key immune pathway genes for both innate adaptive and humoral immune targets as indicated in the Cancer Immunity Cycle, first described by Chen and Mellman (Chen DS, Mellman I. Immunity. 2013;39:1-10).

On November 05, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, reported that new data from the Phase 1/2 clinical trial for IMO-8400, a TLR 7,8 and 9 antagonist, being evaluated for the treatment of relapsed, refractory patients suffering from Waldenström’s Macroglobulinemia, will be presented at the 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, FL, December 5-8, 2015 (Press release, Idera Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107366 [SID:1234508011]).

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The open-label, dose-ranging clinical trial included three dose-escalating cohorts on IMO-8400 and enrolled 19 patients, who were relapsed or refractory to prior therapies. Data from these 19 patients will be presented at the ASH (Free ASH Whitepaper) Meeting.

"The presentation of the clinical safety and efficacy data from our IMO-8400 study in Waldenström’s Macroglobulinemia is a positive step forward for our company, for our clinical aspirations in cancer care and for the role of Toll-Like Receptors as a therapeutic option for patients suffering from B-cell Lymphomas," stated Vincent Milano, Idera’s Chief Executive Officer. "We look forward to presenting the data next month at the ASH (Free ASH Whitepaper) conference and beginning to elucidate the path forward for IMO-8400 beyond this first clinical study."

Poster Presentation

Date: Saturday, December 5, 2015, Presentation Time: 5:30 PM ET – 7:30 PM ET
Session Title: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Publication Number: 1540
Presentation Title: Preliminary Results from a Phase 1/2 Open-Label, Dose-Escalation Clinical Trial of IMO-8400 in Patients with Relapsed or Refractory Waldenström’s Macrogloblulinemia
Location: Orange County Convention Center, Hall A

On November 5, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third quarter 2015 financial results and ongoing progress with its pipeline, including duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma (Press release, Infinity Pharmaceuticals, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107548 [SID:1234508033]). Infinity also announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for the investigation of duvelisib for the treatment of patients with follicular lymphoma (FL) who have received at least two prior therapies. Earlier this year, Infinity received Fast Track designation for the investigation of duvelisib for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Infinity is conducting registration-focused trials evaluating the safety and efficacy of duvelisib, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and DUO, a Phase 3 study in patients with relapsed/refractory CLL.

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"The quarter was marked by important clinical development progress for duvelisib, particularly the completion of patient enrollment in DYNAMO. We are also pleased to have recently received Fast Track designation for the investigation of duvelisib for the treatment of follicular lymphoma in patients who have received at least two prior therapies, which complements our Fast Track designation in CLL and supports our belief in the potential of duvelisib to help fill important medical needs," stated Adelene Perkins, Infinity’s chair, president and chief executive officer. "We are making strong progress toward the completion of patient enrollment in DUO and expect to complete enrollment this quarter. We look forward to completing our regulatory requirements expeditiously to leverage the Fast Track opportunities as we pursue parallel registration paths within iNHL and CLL."

In addition to the DYNAMO and DUO studies, Infinity is conducting CONTEMPO, a Phase 1b/2 study in treatment-naive FL patients, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to begin this year, including the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity and AbbVie are jointly developing duvelisib in oncology.

"At Infinity, our mission is to build a company and a community that can sustainably discover, develop and deliver first-in-class and best-in-class medicines to patients. The recent expansion of our pipeline into solid tumors with the addition of IPI-549 represents an important step toward fulfilling our mission. We are planning to initiate a Phase 1 study of IPI-549 in patients with solid tumors in the first quarter of 2016," Ms. Perkins continued.

In preclinical studies, IPI-549 inhibits immune-suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 has the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring an anti-tumor immune response when used in combination with other immunotherapies such as checkpoint inhibitors.

Recent highlights include the following:

Duvelisib Program

Duvelisib granted Fast Track designation for the treatment of patients with FL: Infinity reported that the FDA granted Fast Track designation for the investigation of duvelisib for the treatment of patients with FL who have received at least two prior therapies. The FDA established the Fast Track designation process to facilitate the development and expedite the review of investigational medicines intended to treat serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need.

Duvelisib data to be presented at ASH (Free ASH Whitepaper) Annual Meeting: Infinity reported that three duvelisib abstracts have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting, which is being held December 5 – 8 in Orlando, Florida. Presentations will include data from preclinical and translational research conducted in collaboration with The Feinstein Institute for Medical Research demonstrating that inhibition of PI3K-delta and PI3K-gamma affect B-cell growth and survival through both direct effects on CLL cells as well as by disrupting the tumor microenvironment. Additionally, clinical data from two investigator-sponsored studies in patients with hematologic malignancies will be presented. The three poster presentations are as follows:

Saturday, December 5, 2015, 5:30 p.m. – 7:30 p.m. ET
Title: Dual inhibition of PI3K-delta and gamma by duvelisib (IPI-145) impairs CLL B- and T-cell migration, survival and proliferation in a murine xenograft model using primary chronic lymphocytic leukemia cells (Abstract #1753)
Lead Author: Shih-Shih Chen, Ph.D., The Feinstein Institute for Medical Research

Monday, December 7, 2015, 6:00 p.m. – 8:00 p.m. ET
Title: Preliminary results of a Phase Ib study of duvelisib in combination with FCR (dFCR) in previously untreated, younger patients with CLL (Abstract #4158)
Lead Author: Matthew Davids, M.D., Dana-Farber Cancer Institute

Title: Combination trial of duvelisib (IPI-145) with bendamustine, rituximab or bendamustine/rituximab in patients with lymphoma or chronic lymphocytic leukemia (Abstract #3928)
Lead Author: Ian Flinn, M.D., Sarah Cannon Research Institute

Target enrollment in DYNAMO reached: In September, Infinity announced it had reached target enrollment in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in approximately 120 patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The enrollment milestone triggered a $130 million milestone payment from AbbVie.

BRAVURA study announced: In October, Infinity announced plans to initiate BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL, in the fourth quarter of 2015. BRAVURA is designed to evaluate the safety and efficacy of duvelisib plus rituximab and bendamustine (RB) compared to placebo plus RB in approximately 600 patients. The primary endpoint is progression-free survival. Infinity is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.

FRESCO study announced: In October, Infinity announced plans to initiate FRESCO, a Phase 2 study in patients with relapsed/refractory FL, in the fourth quarter of 2015. FRESCO is designed to evaluate the safety and efficacy of duvelisib plus rituximab versus rituximab in combination with chemotherapy in approximately 200 patients. The primary endpoint is progression-free survival.

IPI-549 Program

IPI-549 expected to enter Phase 1 clinical development in the first quarter of 2016: In September, Infinity announced the expansion of its pipeline with IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. At the CRI-CIMT-EATI-AACR – The Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper), Infinity researchers reported preclinical data demonstrating the potential of IPI-549 to disrupt the immune-suppressive tumor microenvironment and enable a heightened anti-tumor immune response. Research also showed that IPI-549 demonstrated dose-dependent, single-agent, anti-tumor activity in multiple solid tumor models, including murine models of lung, colon and breast cancer. Additionally, mice treated with IPI-549 in combination with checkpoint inhibitors showed greater tumor growth inhibition than either treatment as a monotherapy.
In the first quarter of 2016, Infinity expects to begin a Phase 1 clinical study of IPI-549 in patients with selected solid tumors, including non-small cell lung cancer and melanoma. The study will evaluate IPI-549 as a monotherapy as well as in combination with an anti–PD-1 antibody therapy.

Corporate Updates

Senior management team augmented: In October, William Bertrand joined Infinity as executive vice president, general counsel. Prior to Infinity, Mr. Bertrand held various roles of increasing responsibility at Salix Pharmaceuticals, Inc. and most recently served as senior vice president, general manager responsible for the Salix commercial business as well as its transition and integration into Valeant Pharmaceuticals International, Inc. From 2001 to 2013, Mr. Bertrand held positions of increasing responsibility at MedImmune, Inc., serving as its first and only general counsel from 2003 to 2013, prior to and following its sale to AstraZeneca PLC in 2008. Prior to MedImmune, Mr. Bertrand served as associate general counsel at Pharmacia Corporation. He earned a B.S. in Biology from Wayne State University and a J.D. from the University of Wisconsin-Madison.

Third Quarter 2015 Financial Results

At September 30, 2015, Infinity had total cash, cash equivalents and available-for-sale securities of $163.0 million, compared to $199.5 million at June 30, 2015, which does not include the $130 milestone payment received from AbbVie in November 2015.
Total revenue during the third quarter of 2015 was $90.7 million, compared to $160.6 million in the third quarter of 2014.
Revenue included a $75.2 million license fee associated with the $130 million milestone payment from AbbVie for the completion of patient enrollment in DYNAMO and $15.5 million in research and development (R&D) services. R&D services revenue for the third quarter of 2015 was composed of $9.8 million associated with the $130 million milestone payment and $5.7 million associated with the $275 million upfront payment from AbbVie received in September 2014. Revenue during the third quarter of 2014 was composed of $159.1 million license fee and $1.5 million in R&D services, both of which related to the $275 million upfront milestone from AbbVie. Infinity will recognize the remainder of the $130 million milestone payment and $275 million upfront payment over the period in which R&D services will be provided.

R&D expense for the third quarter of 2015 was $37.7 million, compared to $44.9 million for the third quarter of 2014. The decrease in R&D expense for the third quarter of 2015 compared to the same period in 2014 was primarily due to a $5.0 million option fee payment to Takeda in the third quarter of 2014 as well as lower clinical development expenses for duvelisib.

General and administrative (G&A) expense was $9.8 million for the third quarter of 2015, compared to $8.0 million for the same period in 2014. The increase in G&A expense was primarily related to the continued build-out of the company’s commercial capabilities and the functional support related to those activities.

Net income for the third quarter of 2015 was $42.5 million, or a basic earnings per common share of $0.85 and a diluted earnings per common share of $0.84. Net income for the third quarter of 2014 was $103.2 million, or a basic earnings per common share of $2.08 and a diluted earnings per common share of $2.03.
2015 Financial Guidance

The company’s 2015 financial outlook is as follows:

Revenue: Infinity expects revenue to range from $100 million to $120 million.
Net Loss: Infinity expects net loss for 2015 to range from $125 million to $145 million.
Cash and Investments: Infinity expects to end 2015 with a year-end cash and investments balance ranging from $230 million to $250 million. This anticipated year-end cash and investments balance includes the $130 million milestone payment from AbbVie associated with the completion of patient enrollment in DYNAMO.
Conference Call Information
Infinity will host a conference call today at 4:30 p.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors/Media" section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 60777175. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Duvelisib
Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.i Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.ii Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

About IPI-549
IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.