On May 4, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three months ended March 31, 2016 (Press release, Delcath Systems, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2164855 [SID:1234511886]).

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Highlights for the first quarter of 2016 and recent weeks include:

Initiation of patient enrollment in the global Phase 3 FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (the FOCUS trial), which is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.
Addition of two prestigious U.S. cancer centers as FOCUS trial clinical sites
Activation of Hacettepe University Clinic in Ankara, Turkey as the first CHEMOSAT commercial treatment center outside of the European Union
Initiation of hospital negotiations for definition of ZE reimbursement levels in Germany
Completion of more than 300 treatments with CHEMOSAT since the second generation of the system was launched
"We began 2016 with strong momentum in our clinical development program, kicking off the year with the acceptance of a SPA agreement with the FDA for initiation of our FOCUS Phase 3 trial," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath. "We are delighted that three leading U.S. cancer centers are now open and several others have committed to participate in the FOCUS trial and we look forward to opening additional trial sites in both the U.S. and Europe over the course of 2016. We made further progress with our Phase 2 trial for hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC) and expect to report interim data on the ICC cohort mid-year.

"We also continued to make steady progress commercializing CHEMOSAT in Europe. In February hospitals in Germany began negotiations to determine coverage levels for CHEMOSAT under the ZE national reimbursement mechanism. We anticipate coverage levels to be defined in mid-to-late 2016, which we believe will enhance growth in procedure volumes in Germany beginning late this year and provide important validation for reimbursement appeals in other markets in Europe.

"In April we announced our first expansion into markets outside of the European Union with the activation of Hacettepe University Clinic in Ankara, Turkey. Hacettepe is a well-regarded cancer treatment center in Turkey, and we believe it will serve as an excellent hub for CHEMOSAT treatments in the entire region.

"We look forward to executing our strategic plan throughout the remainder of the year, which includes multiple presentations and publications of data in support of CHEMOSAT as a treatment for metastatic liver cancers," concluded Dr. Simpson.

First Quarter Financial Results

Total revenue for the first quarter of 2016 was $0.4 million. Selling, general and administrative expenses for the first quarter of 2016 were $2.4 million, an improvement of $0.6 million or 20% from $3.0 million reported for the same period in 2016, primarily attributable to a reduction in severance accruals related to workforce and lease restructurings. Research and development expenses increased to $1.3 million for the 2016 first quarter from $1.0 million for the same period in 2015, primarily due to increased investment in clinical development initiatives.

Total operating expenses for the first quarter of 2016 decreased to $3.7 million from $4.0 million for the same period in 2015. This reflects an increase in clinical development initiatives, partially offset by a reduction in severance and compensation-related expenses following significant workforce and lease restructurings, as well as a reduction in facility expenses.

The Company recorded a net loss for the three months ended March 31, 2016 of $1.8 million, a decrease of $1.7 million or 49% from a net loss of $3.5 million for the same period in 2015. This decrease in net loss is primarily due to a $1.3 million change in the fair value of the warrant liability, a non-cash item and a $0.3 million reduction in operating expenses.

Balance Sheet Highlights

As of March 31, 2016, Delcath had cash and cash equivalents of $9.5 million, compared with $12.6 million as of December 31, 2015. During the first quarter of 2016, the Company used $3.8 million in cash to fund its operating activities. Delcath believes it has sufficient capital to fund its operating activities through the third quarter of 2016.

On May 4, 2016 bluebird bio, Inc. (Nasdaq: BLUE) a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer, reported business highlights and financial results for the first quarter ended March 31, 2016 (Press release, bluebird bio, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2165083 [SID:1234511925]).

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"In early 2016 we achieved two crucial clinical milestones: treating the first patient in the Phase 1 study of our anti-BMCA CAR T therapy bb2121, and presenting the first clinical data from our Starbeam study of Lenti-D in boys with CALD. We are very pleased with this significant progress as we continue to build our T cell immunotherapy and HSC gene therapy platforms," said Nick Leschly, chief bluebird. "On the LentiGlobinTM program, we are on track to achieve our remaining milestones this year, which include initiation of the HGB-207 study in non-ß0/ß0 transfusion-dependent thalassemia (TDT) as well as integration of manufacturing process improvements into our LentiGlobin clinical trials."

Recent Highlights

PRESENTED INTERIM DATA FROM STARBEAM STUDY AT AAN – In April, Dr. Florian Eichler of Massachusetts General Hospital for Children presented interim clinical data from the Starbeam study of Lenti-D in CALD at AAN. Initial Starbeam results suggest Lenti-D gene therapy may have similar efficacy to allogeneic hematopoietic stem cell transplant (HCT), the current standard of care, with a more favorable safety profile. As of March 31, 2016, three of the 17 patients enrolled in the study have reached two years of follow-up and remain free of major functional disabilities (MFDs), the primary endpoint of the study. Sixteen of the 17 patients had stabilization of their neurological function score (NFS), and 14 of 17 had a stable Loes score. The safety profile of Lenti-D treatment appeared consistent with myeloablative conditioning.

TEN ABSTRACTS ACCEPTED FOR PRESENTATION AT ASGCT (Free ASGCT Whitepaper) 19th ANNUAL MEETING – Two oral presentations given by bluebird’s academic collaborators will highlight previously presented data from bluebird bio’s ongoing gene therapy clinical trials, including interim data from the Starbeam Study of Lenti-D in cerebral adrenoleukodystrophy, and interim data from the HGB-205 study of LentiGlobin in severe sickle cell disease and TDT. Eight additional presentations will be featured at the meeting, highlighting progress across the company’s preclinical, research and process development activities in both HSC gene therapy and T cell immunotherapy.

TREATED FIRST PATIENT IN PHASE 1 STUDY OF BB2121 IN MULTIPLE MYELOMA – In February, the first patient was infused in the CRB-401 study of anti-BCMA CAR T therapy bb2121 in relapsed/refractory multiple myeloma. Additionally, Celgene exercised its option to exclusively license bb2121. Under the terms of the collaboration agreement between the two companies, bluebird bio received a $10.0 million option exercise payment from Celgene and may now elect to co-develop and co-promote the product candidate in the United States with Celgene. We are also eligible to receive specified development and regulatory milestone payments and royalty payments on net sales.

FULLY ENROLLED EXPANDED NORTHSTAR STUDY – Achievement of 18 patient enrollment target in Northstar Study of LentiGlobin in patients with transfusion-dependent thalassemia, including three additional adolescent patients.
Upcoming Anticipated Milestones

Update on LentiGlobin process improvements in the second half of 2016
Initiation of the HGB-207 study in patients with TDT with the non-ß0/ß0 genotype in the second half of 2016
Presentation of updated clinical data for LentiGlobin at the ASH (Free ASH Whitepaper) annual meeting in December 2016
First Quarter 2016 Financial Results and Financial Guidance

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2016 were $826.9 million, compared to $865.8 million as of December 31, 2015, a decrease of $38.9 million.
Revenues: Collaboration revenue was $1.5 million for the first quarter of 2016 compared to $6.3 million for first quarter of 2015. The decrease is a result of an amendment to our collaboration agreement with Celgene in the second quarter of 2015.
R&D Expenses: Research and development expenses were $41.9 million for the first quarter of 2016 compared to $23.7 million for the first quarter of 2015. The increase in research and development expenses was primarily attributable to increased employee compensation and facilities costs due to increased headcount, and increased manufacturing, clinical, research, and information technology costs to support the advancement of our clinical and pre-clinical programs.
G&A Expenses: General and administrative expenses were $16.0 million for the first quarter of 2016 compared to $7.3 million for the first quarter of 2015. The increase in general and administrative expenses was primarily attributable to increased employee compensation expense due to increased headcount, and consulting costs to support our overall growth.
Net Loss: Net loss was $56.3 million for the first quarter of 2016 compared to $24.8 million for the first quarter of 2015.
Financial guidance: bluebird bio expects that its cash, cash equivalents and marketable securities of $826.9 million as of March 31, 2016 will be sufficient to fund its current operations through 2018.

On May 04, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the first quarter ending March 31, 2016, and provided a clinical update (Press release, Endocyte, MAY 4, 2016, View Source [SID:1234511887]).

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"We continue to be pleased with the progress of our two lead, clinical-stage assets, EC1456 and EC1169, in Phase 1 dose escalation studies. Both drugs are very well-tolerated and show evidence of anti-tumor activity. Maximum tolerated dose has not yet been reached with either drug," said Ron Ellis, Endocyte’s president and chief executive officer. "We look forward to providing more detailed updates on both of these dose escalation trials at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June."

Endocyte recently announced promising data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, highlighting its preclinical work in the area of immuno-oncology. In collaboration with Purdue University, the company announced a novel approach that makes possible the engineering of a single universal chimeric antigen receptor (CAR) T cell that can be targeted to multiple receptors on cancer cells through the use of unique, small molecule, bispecific adaptors. This approach has the potential to address major challenges faced by other CAR T cell technologies, by improving the management of safety, having a mechanism to address tumor heterogeneity, and lowering the cost of therapy.

Also at AACR (Free AACR Whitepaper), Endocyte announced data reflecting the promise of synergistic activity of its SMDCs in combination with immune modulating therapies. The combination of EC1456 with an anti-PD1 antibody demonstrated curative activity in models expressing PD-L1. It was further demonstrated that treated animals developed an immune response when tumors were re-introduced months after the cessation of therapy.

"These new developments, along with our new lead development candidate in oncology, which deploys a dual mechanism of cytotoxic tumor cell killing plus activity against tumor associated macrophages, demonstrates the range of applications of our SMDC platform," added Ron Ellis. "The ability to target receptors with high specificity and deeply penetrate the tumor microenvironment uniquely positions SMDCs to be effective not only as targeted cytotoxic agents, but also by engaging the immune system to participate in the fight against disease. We look forward to a deeper discussion of the data and the science behind these approaches at a research event later this year."

Upcoming Expected Milestones

Phase 1 dose escalation updates on EC1456 and EC1169 at ASCO (Free ASCO Whitepaper) annual meeting in June 2016
EC1456 single agent efficacy data (tumor response) in non-small cell lung cancer before year-end 2016
EC1169 single agent efficacy data in prostate cancer in late 2016 or 2017
Updates on plans for earlier stage programs

First Quarter 2016 Financial Results

Endocyte reported a net loss of $10.2 million, or $0.24 per basic and diluted share, for the first quarter of 2016, compared to a net loss of $10.9 million, or $0.26 per basic and diluted share, for the same period in 2015.

Research and development expenses were $6.5 million for the first quarter of 2016, compared to $6.6 million for the same period in 2015. The slight decrease was primarily attributable to a decrease in expenses related to the TARGET trial which is now complete and a decrease in discovery research expenses, which were partially offset by an increase in expenses relating to the EC1169 dose escalation trial as well as an increase in compensation expenses, primarily for noncash stock compensation.

General and administrative expenses were $3.8 million for the first quarter of 2016, compared to $4.4 million for the same period in 2015. The decrease in expenses was primarily attributable to a reduction in legal and professional fees in the first quarter of 2016 as compared to the same period in 2015, which was partially offset by an increase in compensation expenses, primarily for noncash stock compensation.

Cash, cash equivalents and investments were $163.3 million at March 31, 2016, compared to $196.8 million at March 31, 2015, and $173.6 million at December 31, 2015.

Financial Expectations

The Company reiterated guidance that it expects its cash balance at the end of 2016 to be between $125 and $130 million.

On May 04, 2016 CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre-implantation genetic diagnostics and screening, miscarriage analysis, prenatal and pediatric diagnostics, reported financial results for the three months ended March 31, 2016 (Press release, CombiMatrix, MAY 4, 2016, View Source [SID:1234511927]).

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"We are reporting another exceptional quarter of financial progress, with 28% revenue growth, expanded gross margin, increased cash collections and well managed operating expenses," said Mark McDonough, CombiMatrix President and CEO. "Our growth was driven by a 39% increase in reproductive health revenue on an 18% increase in test volume, reflecting higher average revenue per test. We are particularly pleased with our performance in miscarriage analysis testing, with revenues up 43% on 13% test volume growth. We also benefited from better productivity from our newer sales representatives, which contributed to an 18% increase in our customer base.

"We anticipate that various industry dynamics will favorably impact our business," he added. "In March, the two leading associations in women’s healthcare, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM), issued revised practice bulletins recommending that all women regardless of age or other risk factors are offered prenatal genetic testing. These bulletins reiterated the need to perform confirmatory testing when screening tests reveal positive results for fetal abnormalities. Additionally, a number of health plans, including Cigna and several in the Blue Cross Blue Shield network, have recently revised their medical policies to cover chromosomal microarray testing for recurrent pregnancy loss. We believe that more health plans will follow suit based on the growing clinical support for this valuable patient information.

"We are firmly focused on growth and a path toward profitability, supported by tight execution of our business strategy," said Mr. McDonough. "This year we plan to expand our IVF testing portfolio and expect to increase physician adoption through more clinical validation, improved marketing developed from the insights from our newly appointed Scientific Advisory Board, and greater productivity from our sales organization. We also are seeking opportunities to build upon our leadership position in the growing reproductive health diagnostics market and enhance shareholder value through partnerships and other business development alternatives. With the completion of an $8 million financing in late March, we are well positioned to execute on our plans."

First Quarter Financial and Operational Highlights (all comparisons are with the first quarter of 2015)

Total revenues of $3.0 million, up 28%
Reproductive health revenues of $2.2 million, up 39%
Reproductive health test volume of 1,426, up 18%
Number of billable customers reaches 264, up 18%
Cash collections of $2.5 million, up 15%
Closed $8.0 million underwritten public offering in March of 2016
Launched CombiPGD – Preimplantation Genetic Diagnosis for Single Gene Disorders and Chromosomal Translocations
Formed Scientific Advisory Board

Volumes
Revenues (in 000’s)
Q1 ’16 Q1 ’15 # Δ % Δ Q1 ’16 Q1 ’15 $ Δ % Δ
Prenatal 264 324 (60 ) (19 %) $ 321 $ 422 $ (101 ) (24 %)
Miscarriage analysis 995 882 113 13 % 1,622 1,132 490 43 %
PGS 167 - 167 - 222 - 222 -
Subtotal – reproductive health 1,426 1,206 220 18 % 2,165 1,554 611 39 %
Pediatric 452 467 (15 ) (3 %) 500 497 3 1 %
Subtotal – all arrays 1,878 1,673 205 12 % 2,665 2,051 614 30 %
Non-array tests 770 672 98 15 % 265 236 29 12 %
Total – all tests 2,648 2,345 303 13 % 2,930 2,287 643 28 %
Royalties 42 42 - 0 %
Total revenues $ 2,972 $ 2,329 $ 643 28 %

Financial Results

Total revenues for the first quarter of 2016 increased 28% to $3.0 million from $2.3 million for the first quarter of 2015. Revenues for the first quarter of 2016 were comprised of $2.9 million of diagnostic services revenue and $42,000 in royalties. Reproductive health diagnostic test revenue, which includes prenatal microarrays, miscarriage analysis and PGS, increased 39% to $2.2 million and related testing volumes increased 18% to 1,426. The first quarter 2016 revenue increase was driven partially by higher test volumes, particularly from miscarriage analysis and PGS testing, but primarily by higher average revenue per test in miscarriage analysis testing.

Total operating expenses were $4.4 million for the first quarter of 2016, compared with $4.1 million for the first quarter of 2015. The increase was due primarily to an increase in cost of services related to higher test volumes and from an increase in sales and marketing expenses related to sales force expansion. Gross margins for the first quarter of 2016 improved to 51.6% from 46.2% for the first quarter of 2015 due primarily to improved average reimbursement on miscarriage analysis testing.

The net loss for the first quarter of 2016 was $1.5 million, or $1.73 per share, compared with a net loss for the first quarter of 2015 of $1.8 million, or $2.24 per share. Net loss attributable to common stockholders for the first quarter of 2016 was $3.1 million, or $3.63 per share, compared with a net loss attributable to common stockholders for the first quarter of 2015 of $2.7 million, or $3.37 per share. The higher net loss attributable to common stockholders in 2016 reflected one-time, non-cash charges of $1.9 million related to deemed dividends from the issuance of Series F convertible preferred stock and warrants in the $8.0 million public offering that closed on March 24, 2016. This increase was partially offset by the reversal of the $890,000 Series E deemed dividend recognized in 2015 from the repurchase of those securities upon closing of our public offering, partially reduced by the $656,000 deemed dividend paid to the Series E investors in February of 2016.

The Company reported $6.6 million in cash, cash equivalents and short-term investments as of March 31, 2016, compared with $3.9 million as of December 31, 2015. The Company used $1.7 million in cash to fund operating activities during the first quarter of 2016, compared with $1.2 million to fund operating activities during the comparable period in 2015. The increase in net cash used to fund operating activities in 2016 resulted primarily from the timing of the purchase of inventory supplies, coupled with higher overall headcount in early 2016 compared with 2015.

On May 4, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its first quarter 2016 financial results and ongoing progress with its pipeline, including duvelisib, an investigational, oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and IPI-549, an immuno-oncology development candidate that selectively inhibits PI3K-gamma (Press release, Infinity Pharmaceuticals, MAY 4, 2016, View Source;p=RssLanding&cat=news&id=2165087 [SID:1234511932]).

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Infinity expects to report topline data from DYNAMO, a registration-focused Phase 2 monotherapy study of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), early in the third quarter of 2016. Infinity also anticipates completing an interim analysis of DUO, a registration-focused Phase 3 monotherapy study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), early in the second half of 2016. The company expects marketing applications, if supported by these data, to be submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the fourth quarter of 2016.

"We believe the next few months will be fundamental to advancing Infinity’s goal of bringing important new medicines to patients. If the duvelisib data that we anticipate in the coming months are favorable, these data could enable regulatory filings to be submitted in the U.S. and Europe in the fourth quarter of 2016. Achieving these milestones positions us to potentially bring duvelisib to patients next year," stated Adelene Perkins, president and chief executive officer. "Infinity is also advancing several clinical studies designed to evaluate the safety and activity of duvelisib in broader patient populations. Additionally, our collaborator, AbbVie, has initiated a Phase 1b/2 clinical study of duvelisib in combination with Venclexta," Ms. Perkins continued.

Recent developments:

Preliminary data from CONTEMPO to be presented in June: Infinity reported that preliminary data from CONTEMPO, a Phase 1b/2 study evaluating duvelisib in combination with rituximab or obinutuzmab in treatment-naïve follicular lymphoma patients, has been accepted for presentation in a poster session at the 21st Congress of European Hematology Association (EHA) (Free EHA Whitepaper), which will take place June 9 – 12, 2016, in Copenhagen.

Phase 1b/2 study of duvelisib in combination with Venclexta initiated: AbbVie has initiated a Phase 1b/2 clinical study of duvelisib in combination with Venclexta, AbbVie’s B-cell lymphoma-2 (BCL-2) selective inhibitor. This study is designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with relapsed or refractory iNHL, aggressive NHL, small lymphocytic lymphoma or CLL.

Preclinical data for IPI-549 presented at the 2016 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April, Infinity researchers in collaboration with researchers at Memorial Sloan Kettering Cancer Center presented preclinical data for IPI-549 at the 2016 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data in multiple solid tumor models demonstrated that IPI-549 targets immune cells and alters the immune-suppressive microenvironment, promoting an anti-tumor immune response that leads to tumor growth inhibition. Data also demonstrated that IPI-549 enhances the effects of checkpoint inhibitors, resulting in improved survival in murine models.
A Phase 1 study of IPI-549 is ongoing to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4): In connection with the appointment of Mr. Christopher Lindblom as vice president, finance and treasurer at Infinity, the Compensation Committee of Infinity’s Board of Directors approved the grant of an option to Mr. Lindblom to purchase 40,000 shares of Infinity’s common stock. The option was granted outside of the company’s equity incentive plans and was made as an inducement material to Mr. Lindblom’s acceptance of employment. The option has an exercise price of $5.87 per share, which is equal to the closing price of Infinity’s common stock on May 2, 2016. One-fourth of the shares underlying Mr. Lindblom’s option will vest on the one year anniversary of his date of hire and thereafter 1/48th of the shares underlying Mr. Lindblom’s option will vest monthly, such that the shares underlying the option will be fully vested on the fourth anniversary of his date of hire, subject to his continued employment with Infinity on each such vesting date.
First Quarter 2016 Financial Results

At March 31, 2016, Infinity had total cash, cash equivalents and available-for-sale securities of $193.0 million, compared to $245.2 million at December 31, 2015.

Revenue during the first quarter of 2016 was $9.3 million for research and development (R&D) services associated with the strategic collaboration with AbbVie for duvelisib in oncology, compared to $4.4 million for R&D services for the first quarter of 2015.

R&D expense for the first quarter of 2016 was $39.2 million, compared to $88.4 million for the first quarter of 2015. R&D expense for the first quarter of 2015 included a $52.5 million payment related to the exercise of an option to buy out the company’s royalty obligations to Takeda Pharmaceutical Company Limited for duvelisib worldwide oncology sales. Excluding the $52.5 million payment in 2015, the increase in R&D expense was primarily due to higher clinical development expenses for duvelisib as well as an increase in staffing.

General and administrative (G&A) expense was $10.8 million for the first quarter of 2016, compared to $8.6 million for the same period in 2015. The increase in G&A expense was primarily related to an increase in staffing as well as external commercial expenses in preparation for the potential launch of duvelisib in 2017.

Net loss for the first quarter of 2016 was $40.7 million, or a basic and diluted loss per common share of $0.82, compared to $93.3 million, or a basic and diluted loss per common share of $1.91, for the same period in 2015.
Conference Call Information
Infinity will host a conference call today, May 4, 2016, 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 89736154. An archived version of the webcast will be available on Infinity’s website for 30 days.

About Duvelisib
Duvelisib is an investigational, 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.

Infinity and AbbVie are conducting a broad clinical development program evaluating duvelisib in patients with hematologic malignancies. In addition to DYNAMO and DUO, ongoing studies include BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. AbbVie has also initiated a clinical study in duvelisib in combination with Venclexta (venetoclax) in patients with relapsed or refractory CLL, small lymphocytic lymphoma, iNHL or aggressive NHL, as well as a Phase 1 study of duvelisib in Japanese subjects with relapsed or refractory lymphoma. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About IPI-549
IPI-549 is an investigational, 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.