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MIRATI THERAPEUTICS REPORTS SECOND QUARTER 2017 FINANCIAL RESULTS

On August 3, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the second quarter 2017 (Filing, Q2, Mirati, 2017, AUG 3, 2017, View Source [SID1234520040]).

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"The second half of 2017 remains on track to be a significant time for all of Mirati’s programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Our team continues to work diligently to deliver the anticipated data for each program this year."

Mirati expects to present data on the following programs in the second half of 2017:
•
Glesatinib, single agent, Phase 2 trial in Non-Small Cell Lung Cancer (NSCLC)
•
Sitravatinib, single agent, Phase 1b trial in NSCLC
•
Sitravatinib and nivolumab combination, Phase 2 trial in NSCLC
•
Mocetinostat and durvalumab combination, Phase 2 trial in NSCLC

Second Quarter 2017 Financial Results

Cash, cash equivalents, and short-term investments were $87.8 million at June 30, 2017, compared to $56.7 million at December 31, 2016.

Research and development expenses for the second quarter of 2017 were $15.0 million, compared to $18.4 million for the same period in 2016. Research and development expenses for the six months ended June 30, 2017 were $29.4 million, compared to $36.4 million for the same period in 2016. The decrease in research and development expenses for both the three and six months ended June 30, 2017 is primarily due a decrease in third party research and development expense, including a reduction in glesatinib manufacturing expenses, as well as expense associated with a one-time license fee incurred in 2016 related to an early stage discovery project. In addition, share-based compensation expense decreased in the six months ended June 30, 2017 compared to the same period of 2016 due to lower exercise prices for options granted during the last half of 2016 and first half of 2017. These decreases in expenses are partially offset by an increase in expenses associated with our ongoing sitravatinib Phase 1b clinical trial.

General and administrative expenses for the second quarter of 2017 were largely unchanged compared to the same period of 2016 and were $3.7 million and $3.8 million, respectively. General and administrative expenses for the six months ended June 30, 2017 were $7.3 million, compared to $7.9 million for the same period in 2016. The decrease in general and administrative expense is primarily due to a decrease in share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and the first half of 2017.

Net loss for the second quarter of 2017 was $18.3 million, or $0.74 per share basic and diluted, compared to net loss of $22.1 million, or $1.11 per share basic and diluted for the same period in 2016. Net loss for the six months ended June 30, 2017 was $36.2 million, or, $1.47 per share basic and diluted, compared to net loss of $44.0 million, or $2.24 per share basic and diluted for the same period in 2016.

Juno Therapeutics Reports Second Quarter 2017 Financial Results

On August 3, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported financial results and business highlights for the second quarter 2017 (Press release, Juno, AUG 3, 2017, View Source [SID1234520038]).

"It has been a historic last several months for the CAR T field, highlighting the potential of these therapies for patients. Juno is well-positioned to make a major impact, particularly with the potential best-in-class profile emerging for JCAR017," said Hans Bishop, Juno’s President and Chief Executive Officer. "We look forward to starting the pivotal cohort for JCAR017 this quarter as well as expanding the use of this drug into broader populations over the coming year."

Second Quarter 2017 Highlights
Clinical Update:
JCAR017 in DLBCL – Investigators presented interim results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and International Conference of Malignant Lymphoma meetings in June 2017 from the Phase I TRANSCEND study in patients with r/r diffuse large B cell lymphoma (DLBCL) who were treated with fludarabine/cyclophosphamide (flu/cy) lymphodepletion and JCAR017. The core group (N=44) includes patients that represent the population that Juno plans to move forward with for the pivotal cohort. The core group includes patients with DLBCL (de novo and transformed from follicular lymphoma) that are ECOG Performance Status 0-1. Topline results for both dose levels for the core group as of a data cutoff date of May 4, 2017 included:
Overall response rate (ORR) was 86% (38/44) and the complete response (CR) was 59% (26/44).
Three-month ORR was 66% (21/32) and CR was 50% (16/32). Of patients in response at three months, 90% (9/10) continued in response at six months.

Early data suggested a dose response relationship at three months with dose level 2 (100 million cells) ORR of 78% (7/9) and CR of 56% (5/9) as compared to dose level 1 (50 million cells) ORR of 58% (11/19) and CR of 42% (8/19).

97% (37/38) of responding patients were alive and in follow-up as of data cutoff date.

2% (1/44) experienced severe CRS and 18% (8/44) experienced severe NT.

66% (29/44) did not experience any CRS or NT. No deaths were reported from CRS or NT.

Corporate News:
Hired key talent to our leadership team, including the appointment of Sunil Agarwal, M.D. as President of Research & Development. Dr. Agarwal is responsible for the execution of Juno’s drug development pipeline, integration of translational insights into ongoing programs, and the prioritization of research and development initiatives.

Appointments to Board of Directors of Jay Flatley, Executive Chairman of Illumina, Inc. and Rupert Vessey, MA, BM BCh, FRCP, DPhil, Celgene Corporation’s President of Research and Early Development.

Second Quarter 2017 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2017 were $801.8 million compared to $850.7 million as of March 31, 2017 and $922.3 million as of December 31, 2016.

Cash Used in Operating Activities and Capital Expenditures: For the second quarter of 2017 cash used in operating activities was $38.0 million and cash used for capital expenditures was $21.8 million, compared to $2.2 million provided by operating activities and $7.4 million used for capital expenditures for the same period in 2016.

Cash Burn: Cash burn, which is cash used in operating activities and capital expenditures, excluding cash inflows and outflows from upfront payments related to business development activities, was $59.8 million in the second quarter of 2017, of which $56.9 million was operating cash burn and $2.9 million was cash burn for capital expenditures, compared to cash burn of $5.2 million, of which $2.2 million was an operating cash inflow and $7.4 million was cash burn for capital expenditures for the same period in 2016. For purposes of comparing the operating cash burn and cash burn for capital expenditures to the Company’s financial guidance, a cash inflow of $18.9 million for a tenant improvement allowance was reclassified from operating activities to capital expenditures. The increase in cash burn of $54.6 million was primarily driven by the $50.0 million cash inflow from Celgene in the second quarter of 2016 related to the CD19 License.

Revenue: Revenue for the three and six months ended June 30, 2017 was $21.3 million and $40.6 million, respectively, compared to $27.6 million and $37.4 million for the three and six months ended June 30, 2016, respectively. The decrease in the three months ended June 30, 2017 compared to the prior year period was due to milestone revenue recognized in the second quarter of 2016 in connection with the Novartis sublicense agreement.

The increase in the six months ended June 30, 2017 compared to the prior year period was primarily due to revenue recognized under our Celgene Collaboration Agreement and Celgene CD19 License for the upfront license fee and partial reimbursement by Celgene of research and development costs incurred by us in the first and second quarters of 2017, offset by milestone revenue recognized in the six months ended June 30, 2016 related to the Novartis sublicense agreement.

R&D Expenses: Research and development expenses for the three and six months ended June 30, 2017, inclusive of non-cash expenses and computed in accordance with GAAP, were $101.1 million and $184.0 million, respectively, compared to $72.3 million and $146.0 million for the three and six months ended June 30, 2016, respectively. The increases in 2017 compared to 2016 were primarily due to increased costs to manufacture Juno’s product candidates, execute on Juno’s clinical development strategy, and expand its overall research and development capabilities, an increase in expense related to its success payment and contingent consideration obligations, expense incurred for the amortization of the intangible asset associated with the AbVitro, Inc. ("AbVitro") acquisition, and an increase in non-cash stock-based compensation expense. These increases were offset by a decrease in milestone expense.

Non-GAAP R&D Expenses: Non-GAAP research and development expenses for the three and six months ended June 30, 2017 were $77.8 million and $152.2 million, respectively, and include $10.1 million and $19.8 million of stock-based compensation expense, respectively. Non-GAAP research and development expenses for the three and six months ended June 30, 2016 were $72.1 million and $152.3 million, respectively, and include $8.9 million and $18.0 million of stock-based compensation expense, respectively. Non-GAAP research and development expenses for the first half of 2017 exclude the following:

An expense of $17.2 million and $24.6 million for the three and six months ended June 30, 2017, respectively, associated with the change in the estimated fair value and elapsed service period for Juno’s potential success payment liabilities to Fred Hutchinson Cancer Research Center ("FHCRC") and Memorial Sloan Kettering Cancer Center ("MSK").

Non-cash stock-based compensation expense of $0.9 million and $1.6 million for the three and six months ended June 30, 2017, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.

An expense of $2.4 million for the three and six months ended June 30, 2017 associated with amortization of the intangible asset recorded in connection with the AbVitro acquisition.

An expense of $2.7 million and $3.2 million for the three and six months ended June 30, 2017, respectively, associated with the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions.

Non-GAAP research and development expenses for the first half of 2016 exclude the following:
An expense of $3.5 million for the three months ended June 30, 2016 and a gain of $3.1 million for the six months ended June 30, 2016 associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and MSK.

Non-cash stock-based compensation expense of $1.2 million and $2.4 million for the three and six months ended June 30, 2016, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.

A gain of $4.5 million and $5.5 million for the three and six months ended June 30, 2016, respectively, associated with the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions.

G&A Expenses: General and administrative expenses on a GAAP basis for the three and six months ended June 30, 2017 were $23.6 million and $44.3 million, respectively, compared to $16.8 million and $32.8 million for the same periods in 2016. The increases in 2017 compared to 2016 were primarily due to an increase in consulting and other expenses to support the growing organization including costs related to commercial readiness, increased personnel expenses primarily related to increased headcount to support the business, and an increase in stock-based non-cash compensation expense. The increases in the six month period were partially offset by decreased business development expenses. General and administrative expenses include $6.9 million and $13.0 million of non-cash stock-based compensation expense for the three and six months ended June 30, 2017, respectively, compared to $5.5 million and $10.4 million for the three and six months ended June 30, 2016.

GAAP Net Loss: Net loss for the three and six months ended June 30, 2017 was $100.7 million, or $0.96 per share, and $182.9 million, or $1.76 per share, respectively, compared to $64.8 million, or $0.64 per share and $135.9 million, or $1.35 per share, for the three and six months ended June 30, 2016, respectively.

Non-GAAP Net Loss: Non-GAAP net loss, which incorporates the non-GAAP R&D expense, for the three and six months ended June 30, 2017 was $77.5 million, or $0.74 per share, and $151.1 million, or $1.45 per share, respectively, compared to $64.6 million, or $0.64 per share, and $142.1 million, or $1.41 per share for the three and six months ended June 30, 2016, respectively.

Reconciliations of cash burn to GAAP cash used in operating activities and capital expenditures, non-GAAP net loss to GAAP net loss, and non-GAAP R&D expense to GAAP R&D expense are presented below under "Non-GAAP Financial Measures."

2017 Financial Guidance
Juno reaffirms 2017 cash burn, which is cash used in operating activities and capital expenditures, excluding cash inflows or outflows from upfront payments related to business development activities, of between $270 million and $300 million.

Operating burn estimated to be between $245 million and $275 million.

Capital expenditures, net of tenant improvement allowances, estimated to be between $22 million and $27 million, the majority of which are related to one-time infrastructure build-outs.

Insys Therapeutics Reports Second Quarter 2017 Results

On August 3, 2017 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the second quarter ended June 30, 2017 and provided a business update (Press release, Insys Therapeutics, AUG 3, 2017, View Source [SID1234520036]).

Business Update

On track to report top-line results from phase 3 CONVERT study in September plus or minus one month. The CONVERT study, or INS-212, is evaluating amikacin liposome inhalation suspension (ALIS) in treatment refractory NTM lung disease caused by MAC. The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ALIS plus multi-drug regimen arm compared to the multi-drug regimen without ALIS arm. The Company reported that the last patient in the study has progressed beyond the Month 6 measure. Additionally, Insmed reported that the dropout rate observed in the study was lower than the initially assumed dropout rate.

Plan to initiate enrollment of phase 2 dose-ranging study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in the second half of 2017. INS1007 is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Pending dialogue with the FDA, Insmed plans to evaluate two doses of INS1007 (10mg and 25mg) vs. placebo over 24 weeks. The primary endpoint is expected to evaluate time to first exacerbation while secondary endpoints are expected to evaluate mechanistic, clinical and outcomes-based measures. Insmed is also evaluating the potential of INS1007 in other indications.

The FDA provides established name for lead development program. The FDA recently advised Insmed that the established name for its phase 3 product candidate in development for the treatment of refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) will be amikacin liposome inhalation suspension, or ALIS.

Enhanced management team with appointment of chief financial officer, chief medical officer and chief product strategy officer. During the second quarter the company announced changes to its senior leadership team with the appointment of Paolo Tombesi as chief financial officer and Paul Streck, M.D., as chief medical officer. Additionally, Eugene Sullivan, M.D., assumed the newly created role of chief product strategy officer.
"Throughout 2017 we have remained committed to our mission of transforming the lives of patients with rare diseases. We continue to focus on the execution and evaluation of our phase 3 CONVERT study for which we continue to anticipate top-line results in September plus or minus one month. If the study meets the primary endpoint, we intend to complete preparation for a U.S. regulatory filing with the FDA, under Subpart H, for the treatment of patients with refractory NTM," said Will Lewis, president and chief executive officer of Insmed. "Our pre-commercialization activities are also accelerating, as is our assessment of the regulatory pathway beyond the U.S. with a particular focus on Japan. We are also moving ahead with our planning for life cycle management for ALIS and advancing our pipeline."

Second Quarter Financial Results

For the second quarter of 2017, Insmed reported a net loss of $44.7 million, or $0.72 per share, compared with a net loss of $36.6 million, or $0.59 per share, for the second quarter of 2016.

Research and development expenses were $26.9 million for the second quarter of 2017, compared with $23.9 million for the second quarter of 2016. The increase was primarily due to an increase in expenses related to INS1007 and higher compensation and related expenses due to an increase in headcount partially offset by decreases in ALIS manufacturing expenses.

General and administrative expenses for the second quarter of 2017 were $16.6 million, compared with $12.3 million for the second quarter of 2016. The increase was primarily due to higher expenses related to our pre-commercial planning activities for ALIS and higher compensation and related expenses due to an increase in headcount, as compared to the prior year period.

Balance Sheet and Other Financial Highlights

As of June 30, 2017, Insmed had cash and cash equivalents of approximately $91 million. The Company’s operating expenses for the second quarter of 2017 were approximately $44 million, and its cash-based operating expenses (as defined below) for the second quarter of 2017 were approximately $38 million. Insmed ended the second quarter of 2017 with approximately $55 million in debt.

Insmed Reports Second Quarter 2017 Financial Results and Provides Business Update

Infinity Provides Company Update and Reports Second Quarter 2017 Financial Results

On August 3, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its second quarter 2017 financial results and provided an update on the company, including its progress with IPI-549, an oral immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma) (Press release, Infinity Pharmaceuticals, AUG 3, 2017, View Source [SID1234520032]).

Infinity is evaluating IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in a four-part Phase 1 study in patients with advanced solid tumors. Infinity announced today that it has completed an evaluation of escalating monotherapy doses of IPI-549 ranging from 10 mg once daily (QD) to 60 mg QD and has selected the 60 mg dose for evaluation in the monotherapy expansion component of the study. The selection of the 60 mg QD dose was based on pharmacokinetic and pharmacokinetic analyses, which showed that IPI-549 maintained full suppression of PI3K-gamma at this dose level. Data also showed that the IPI-549 dosed at 60 mg QD was well tolerated, and no dose-limiting toxicities were observed. The monotherapy expansion component of the study is now open for enrollment and will evaluate the safety and activity of IPI-549 dosed at 60 QD in approximately 25 patients.

Dose escalation evaluating IPI-549 in combination with Opdivo is ongoing, and Infinity expects to initiate the combination expansion component of the study in the second half of 2017. IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.

"We have initiated the monotherapy expansion component of our Phase 1 study and are eager to also move forward with the combination expansion, allowing us to generate additional clinical and translational data from monotherapy treatment as well as from the combination of IPI-549 and Opdivo in specific types of solid tumors," stated Adelene Perkins, Infinity’s chair and chief executive officer. "We also recently undertook an important strategic initiative and amended our license agreement with Takeda Oncology for IPI-549. We issued Takeda an unsecured $6.0 million convertible note in exchange for eliminating future royalty obligations on IPI-549. This amendment reflects our strong belief in the potential of IPI-549 to be a first-in-class, oral immuno-oncology therapy and reduces the total royalty burden on any future net sales of IPI-549 to four percent due to Mundipharma and Purdue from a previous agreement."

The ongoing Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and activity of IPI-549 as a monotherapy and in combination with the approved dose of Opdivo in approximately 175 patients with advanced solid tumors. The study includes four parts: monotherapy dose escalation, combination therapy dose escalation, monotherapy expansion and combination therapy expansion. The combination expansion component of the study will include multiple cohorts designed to evaluate IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. There is a great need for additional treatment options for the growing number of patients living with these cancers, which account for more than 17 percent of all new cancer cases in the U.S.1,2

Recent Developments

Agreement with Takeda Oncology amended: In July, Infinity amended its license agreement with Takeda Oncology for IPI-549. Under the amended agreement, Infinity will no longer have an obligation to pay Takeda future royalties on worldwide net sales of selective inhibitors of PI3K-gamma, including IPI-549. In exchange for eliminating the royalty obligation, Infinity issued to Takeda an unsecured $6.0 million convertible note that matures on July 26, 2018, and accrues interest at an annual rate of eight percent. The company is obligated to pay the principal amount together with any accrued interest on or before the maturity date in cash or in shares of Infinity common stock, at the election of Takeda. The share payment price would equal the average closing price of Infinity’s common stock for the 20 days prior to the payment date.

Infinity remains obligated to pay development, regulatory and commercial milestones to Takeda for IPI-549. The remaining milestones comprise up to a total of $5 million in development milestones, up to $50 million in success-based regulatory milestones, and up to $115 million in commercial milestones, which are due once certain sales thresholds have been met.

Under a previous agreement, Infinity is obligated to pay Mundipharma International Corporation Limited and Purdue Pharmaceutical Products L.P. a four percent royalty in the aggregate on worldwide net sales of IPI-549, which steps down to one percent in the U.S. after a certain sales threshold is met.
Recommended IPI-549 monotherapy dose determined and monotherapy expansion initiating: Infinity reported today that it has completed patient enrollment in the monotherapy dose-escalation component of the Phase 1 study and has selected IPI-549 dosed at 60 mg QD as the recommended dose for evaluation in the monotherapy expansion. Infinity selected the 60 mg QD dose based on pharmacokinetic and pharmacodynamic analyses, which showed that IPI-549 maintained full suppression of PI3K-gamma at this dose level. Data also showed that IPI-549 dosed at 60 mg QD was well tolerated, and no dose-limiting toxicities were observed. The monotherapy expansion is now open for patient enrollment.
IPI-549 combination dose escalation ongoing: Infinity also announced today that it is continuing to evaluate data from the dose-escalation component of the Phase 1 study assessing IPI-549 30 mg QD in combination with the approved dose of Opdivo. The company expects to complete combination dose escalation and initiate the combination expansion component of the study in the second half of 2017.
Presentation of preclinical rationale for IPI-549 at Precision: Lung Cancer World R&D Summit: In July, Jeffery Kutok, M.D., Ph.D., Infinity’s chief scientific officer, gave an oral presentation entitled "Reprogramming Tumor-Associated Macrophages by Targeting PI3K-Gamma with IPI-549" at the 2017 Precision: Lung Cancer World R&D Summit held in Boston, MA. In his presentation, Dr. Kutok discussed the preclinical rationale for targeting PI3K-gamma previously reported in two publications in Nature.3,4. Preclinical research in solid tumor models has demonstrated that PI3K-gamma blockade in tumor-associated macrophages by IPI-549 results in a transcriptional reprogramming of the M2, or pro-tumor macrophage phenotype, to the M1, or anti-tumor phenotype. In this setting, IPI-549 was active as a monotherapy and showed even greater activity in combination with checkpoint inhibitor therapies. Importantly, in specific models resistant to checkpoint inhibitor therapy, IPI-549 in combination with checkpoint inhibitors was able to overcome this resistance. Taken together, these preclinical data demonstrate that PI3K-gamma plays a key role in the immuno-suppressive tumor microenvironment and provide a strong rationale for the ongoing Phase 1 study.

Dr. Kutok also summarized the Phase 1 clinical data previously reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. These data demonstrated that IPI-549 was well tolerated both as a monotherapy and in combination with Opdivo.5 Additionally, data from the monotherapy component of the study showed IPI-549 has a favorable pharmacokinetic and pharmacodynamic profile that supports once daily dosing.5
Exited lease for Infinity’s office facility at 784 Memorial Drive: In June, Infinity exited its lease agreement for its office facility, allowing the lease to end effective August 31, 2017. Infinity made a termination payment of $4.5 million in June 2017 and will make a final payment of $0.5 million in August 2017. The original lease agreement was to expire in March 2025. Future payment obligations on the lease, excluding operating costs and taxes, as of June 30, 2017, decreased from $16.9 million to $0.2 million. Infinity will be moving into office space with a significantly smaller lease obligation.
Second Quarter 2017 Financial Results

At June 30, 2017, Infinity had total cash and cash equivalents of $66.2 million, compared to $75.4 million at March 31, 2017. Cash used for operating activities during the second quarter of 2017 included payments of $0.8 million related to the company’s 2016 restructuring activities and $4.5 million related to exiting the company’s lease for 784 Memorial Drive.
Infinity did not record any revenue during the second quarter of 2017. Revenue for the second quarter of 2016 was $9.5 million, all of which related to Infinity’s previous collaboration agreement with AbbVie Inc.
Research and development (R&D) expense for the second quarter of 2017 was $3.9 million, compared to $52.9 million for the same period in 2016. The decrease in R&D expense was primarily due to the decrease in clinical development expenses following Infinity’s out-license of duvelisib in addition to the company’s 2016 restructuring activities.
General and administrative (G&A) expense was $6.2 million for the second quarter of 2017 compared to $15.7 million for the same period in 2016. The decrease in G&A expense was primarily due to the company’s 2016 restructuring activities.
Other expense of $6.9 million for the second quarter of 2017 related to expense recognized to exit the company’s facility lease agreement.
Net loss for the second quarter of 2017 was $17.0 million, or a basic and diluted loss per common share of $0.34, compared to net income of $53.0 million, or a basic and diluted earnings per common share of $1.05, for the second quarter of 2016. During the second quarter of 2016, Infinity recorded a non-recurring gain on AbbVie opt-out of the duvelisib collaboration of $112.2 million.
Cash and Investments Outlook
Infinity’s 2017 financial outlook remains as follows:

Net loss: Infinity expects net loss for 2017 to range from $40 million to $50 million.
Cash and Investments: Infinity expects to end 2017 with a cash, cash equivalents and available-for-sale securities balance ranging from $40 million to $50 million.
Based on its current operational plans, Infinity expects that its existing cash and cash equivalents at June 30, 2017, will be adequate to satisfy the company’s capital needs into the first quarter of 2019. The company’s financial outlook excludes additional funding or business development activities.

Conference Call Information
Infinity will host a conference call today, August 3, 2017, 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 40376609. An archived version of the webcast will be available on Infinity’s website for 60 days.

About the IPI-549 and the Ongoing Phase 1 Study
IPI-549 is an investigational, orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor to an anti-tumor phenotype and is able to overcome resistance to checkpoint inhibition.3,4 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.

A Phase 1 study of IPI-549 in patients with advanced solid tumors is ongoing to explore the activity, safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in patients with advanced solid tumors.6 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. The expansion component of the study evaluating IPI-549 plus Opdivo will include patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN). Patients enrolled in these combination expansion cohorts represent a difficult-to-treat population, as they must have demonstrated initial resistance or subsequently develop resistance to a PD-1 or PD-L1 therapy immediately prior to enrolling in the study. Overall, the study is expected to enroll approximately 175 patients.

IPI-549 is an investigational compound and its safety and efficacy has not been evaluated by the U.S. Food and Drug Administration or any other health authority.