On November 7, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, reported its financial results for the third quarter ended September 30, 2017 (Press release, Syndax, NOV 7, 2017, View Source [SID1234521690]). In addition, the Company provided a clinical and business update. As of September 30, 2017, Syndax had $120.6 million in cash, cash equivalents and short-term investments.

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The Company continues to expand its pipeline, and recently announced that it has entered into an exclusive worldwide license agreement with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc, for a portfolio of preclinical, orally-available small molecule inhibitors of the interaction of Menin with the Mixed Lineage Leukemia ("MLL") protein. Syndax plans to initially study these compounds for the treatment of a genetically-defined subset of acute leukemias with chromosomal rearrangements in the MLL gene ("MLL-r").

All four cohorts of ENCORE 601, an open-label, Simon two-stage design, Phase 1b/2 clinical trial evaluating the combination of entinostat, the Company’s class I selective HDAC inhibitor, plus Merck’s anti-PD-1 (programmed death receptor-1) blocking therapy, KEYTRUDA, continue to proceed on schedule. Enrollment in the first stage of the cohort of patients with microsatellite stable colorectal cancer (MSS-CRC) is complete, and a decision on whether to continue to the second stage is expected in the first quarter of 2018. Enrollment in the second stage of the PD-(L)1 refractory non-small cell lung cancer (NSCLC) cohort is complete, and Syndax expects to share updated data from this cohort in the first half of 2018.

"As we near the end of 2017, the momentum we’ve built throughout the year continues to yield meaningful progress and growth for our pipeline of potential best-in-class candidates," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "The recent expansion of our pipeline represents what we believe will be a long-term value enhancing transaction for the Company, while also potentially changing the treatment paradigm for acute leukemic patients harboring MLL translocations, where there exists a high unmet need. For entinostat, the ENCORE 601 program remains on track and we look forward to presenting data from both NSCLC cohorts, as well as biomarker data from the melanoma cohort, at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. We are also developing a global registration plan for entinostat in combination with a PD-1 inhibitor for patients with PD-1 refractory melanoma. We anticipate sharing details of our plan in the first half of 2018, in parallel with the full Phase 2 data from the melanoma cohort of ENCORE 601.

Pipeline Updates

The Phase 3 registration trial of entinostat plus exemestane in advanced HR+, HER2- breast cancer, E2112, is 83% enrolled as of the end of October. ECOG-ACRIN Cancer Research Group, the trial sponsor, has notified the Company that the Data Safety Monitoring Committee (DSMC) completed the final progression free survival analysis and the first interim analysis for overall survival. The results of this analysis are held confidentially by the ECOG-ACRIN study statistician and the DSMC. No communication regarding this analysis will be released until completion of enrollment, which ECOG-ACRIN expects will occur in the first half of 2018.
The ENCORE 601 cohort enrolling NSCLC patients naïve to PD-(L)1 therapy has satisfied the pre-specified efficacy criteria for advancement to the second stage, with ≥ 4 responses out of 17.
Enrollment in the second stage of the ENCORE 601 cohort enrolling patients with PD-(L)1 refractory NSCLC is complete. Data from this cohort is expected to be available in the first half of 2018.
Following a meeting with the U.S. Food and Drug Administration (FDA) in June, the Company is continuing to meet with individual regulatory agencies in Europe to align on a global registration plan for entinostat in combination with a PD-1 inhibitor for patients with PD-(L)1 refractory melanoma. The Company anticipates being in a position to outline a regulatory plan for this indication around the time that full Phase 2 data from the melanoma cohort of ENCORE 601 are available in the first half of 2018.
An oral presentation highlighting the data from stage one of both the ENCORE 601 NSCLC cohorts, as well as a poster presentation covering the biomarker data from the ENCORE 601 melanoma cohort, will be presented at the upcoming Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The Company anticipates sharing full Phase 2 trial data from both the PD-(L)1 refractory NSCLC and melanoma cohorts at a medical congress in the first half of 2018. Details on both SITC (Free SITC Whitepaper) presentations are available here.
Enrollment in the first stage of the cohort enrolling patients with microsatellite stable (MSS)–CRC is complete, and a decision on whether to advance to the second stage is expected in the first half of 2018. At least 2 confirmed objective responses are required to proceed to the second stage.
Enrollment continues in the ENCORE 602 and ENCORE 603 trials, both of which are aimed at exploring the ability of entinostat to enhance the efficacy of checkpoint (PD-L1) inhibitor therapies. ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech’s PD-L1 inhibitor, TECENTRIQ, in patients with triple negative breast cancer, is now expected to complete enrollment in the Phase 2 portion in the first half of 2018, with results anticipated in the second half of the year. ENCORE 603, the Phase 1b/2 clinical trial evaluating entinostat in combination with Pfizer/Merck KGaA’s BAVENCIO in patients with ovarian cancer, continues to enroll patients into the Phase 2 portion and is on track to complete enrollment in the first half of 2018, with results anticipated in the first half of 2019.
Dosing of patients with solid tumors in the Phase 1 multiple ascending dose (MAD) clinical trial of SNDX-6352, the Company’s anti-CSF-1R monoclonal antibody, has commenced. A poster highlighting the safety, pharmacokinetic and pharmacodynamic data from the single ascending dose (SAD) trial of SNDX-6352 in healthy volunteers will be presented at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. Details on the presentation are available here.
The Company entered into an exclusive worldwide license agreement with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc, for a portfolio of preclinical, orally-available small molecule inhibitors of the interaction of Menin with the MLL protein. These compounds have potential application in the treatment of a genetically-defined subset of acute leukemias with chromosomal rearrangements in the MLL gene ("MLL-r"). The Company expects to initiate clinical trials in 2019.

Third Quarter 2017 Financial Results

As of September 30, 2017, Syndax had cash, cash equivalents and short-term investments of $120.6 million and 22.3 million shares issued and outstanding. In October 2017, the Company reported the sale of 2.0 million common shares in a registered direct offering with net proceeds of $24.8 million.

Third quarter 2017 research and development expenses decreased to $12.2 million from $12.3 million for the comparable period in the prior year. The decrease was primarily due to increased clinical trial activities of $3.9 million and increased employee compensation expense of $0.9 million, offset by a $5.0 million upfront payment in 2016 related to the in-license of SNDX-6352 from UCB. The increase in clinical trial activities was primarily due to additional cohorts added to ENCORE 601, increased activities in ENCORE 602 and ENCORE 603, costs related to SNDX-6352, Phase 1 clinical pharmacology trials and CMC activities. The increase in employee compensation costs was primarily due to increased headcount.

General and administrative expenses totaled $3.6 million during the third quarter of 2017 compared with $3.3 million in the comparable period in the prior year. The increase in general and administrative expenses was primarily due to an increase in non-cash stock-based compensation of $0.4 million and an increase in salary expense of $0.2 million due to increased headcount, offset by decreased legal fees of $0.3 million.

For the three months ended September 30, 2017, Syndax reported a net loss attributable to common stockholders of $15.1 million, or $0.68 per share, compared to $15.0 million, or $0.84 per share, for the comparable prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the fourth quarter and full year 2017. For the fourth quarter and full year 2017, research and development expenses are expected to be $15 to $18 million and $47 to $50 million, respectively, and total operating expenses are expected to be $19 to $22 million and $63 to $66 million, respectively. Research and development expenses for the fourth quarter includes $5.0 million paid to Allergan in connection with the Menin-MLL license. This expense will be offset on a cash basis with a $5.0 million development milestone earned in the fourth quarter under our agreement with KHK.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, November 7, 2017.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4569859
Domestic Dial-in Number: 1-855-251-6663
International Dial-in Number: 281-542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On November 7, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test (Press release, Hoffmann-La Roche, NOV 7, 2017, View Source [SID1234521630]). The approval is based on results from the phase III ALEX study, which showed Alecensa significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 47% (HR=0.53, 95% CI: 0.38, 0.73, p<0.0001) compared to crizotinib as assessed by independent review committee (IRC). Median PFS was 25.7 months (95% CI: 19.9, not estimable) for people who received Alecensa compared with 10.4 months (95% CI: 7.7, 14.6) for people who received crizotinib. The safety profile of Alecensa was consistent with that observed in previous studies. The study also showed that Alecensa significantly reduced the risk of the cancer spreading to or growing in the brain or central nervous system (CNS) compared to crizotinib by 84% (HR=0.16, 95% CI: 0.10, 0.28, p<0.0001). This was based on a time to CNS progression analysis in which there was a lower risk of progression in the CNS as the first site of disease progression for people who received Alecensa (12%) compared to people who received crizotinib (45%).

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"Our goal is to develop medicines that have the potential to significantly improve upon the standard of care," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "In our pivotal study, Alecensa significantly extended the time that people lived without their disease worsening compared to crizotinib and also showed a marked reduction in the risk of their cancer spreading to the brain."

Alecensa received Breakthrough Therapy Designation from the FDA in September 2016 for the treatment of adults with advanced ALK-positive NSCLC who have not received prior treatment with an ALK inhibitor. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. Results from the phase III ALEX study were simultaneously presented at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The New England Journal of Medicine. Subsequently, Alecensa was recommended in the National Comprehensive Cancer Network (NCCN) guidelines as a treatment option for first-line ALK-positive metastatic NSCLC (Category 1, Preferred).

In addition to today’s approval, the FDA also converted Alecensa’s initial accelerated approval in December 2015 for the treatment of people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib (second-line) to a full approval.

About the ALEX study1
ALEX (NCT02075840/B028984) is an open-label, randomised, active-controlled, multicentre, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in people with ALK-positive NSCLC who had not received prior systemic therapy for metastatic disease and whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, a immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. People were randomised (1:1) to receive either Alecensa or crizotinib. The major efficacy outcome measure of the ALEX study is PFS according to RECIST v1.1 as determined by investigator assessment. Additional efficacy outcome measures include: PFS as determined by IRC, time to CNS progression by IRC based on RECIST v1.1, objective response rate (ORR) and duration of response (DOR), and overall survival (OS). Additional exploratory outcome measures were CNS-ORR and CNS-DOR by IRC in people with measurable CNS metastases at baseline. The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data are currently considered immature with only about a quarter of events being reported.

Grade ≥ 3 adverse reactions were reported for 41% of patients treated with Alecensa. The most common Grade 3-4 adverse reactions (≥3%) were evidence of kidney dysfunction (increased creatinine; 4.1%), evidence of liver dysfunction (hyperbilirubinemia; 5%), low levels of sodium (hyponatremia; 6%), increased liver enzymes (aspartate transaminase; 6%, and alanine transaminase; 6%), and decreased red blood cells (anaemia; 7%). Serious adverse reactions reported in ≥2% of patients treated with Alecensa were lung infection (pneumonia; 4.6%) and renal impairment (3.9%).

About Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.1 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.3
Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia, Singapore, Taiwan, Liechtenstein, Thailand, United Arab Emirates, Saudi Arabia, Argentina and Turkey for the treatment of people with advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in Japan for people with ALK-positive NSCLC.

About Roche in lung cancer
Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

Aclaris Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Aclaris Therapeutics, 2017, NOV 7, 2017, View Source [SID1234521657]).

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Acorda Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Acorda Therapeutics, 2017, NOV 7, 2017, View Source [SID1234521699]).

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On November 7, 2017 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its third 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, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2314924 [SID1234521651]). 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 1/1b study in patients with advanced solid tumors. In preclinical studies, IPI-549 reprograms macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development.

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On November 10, 2017, a late-breaking abstract summarizing data from the recently completed monotherapy dose-escalation component of the study will be presented at the 2017 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place in National Harbor, MD. The presentation, which will be made during an oral session on new agents, will include an analysis of the safety, activity, pharmacokinetics and pharmacodynamics of IPI-549 in 19 patients who received once daily (QD) doses of IPI-549 ranging from 10 mg to 60 mg. Initial translational data describing how inhibiting PI3K-gamma may elicit an immune response and identifying potential biomarkers of immune response will also be presented. In August, Infinity announced that the company designated the 60 mg QD dose for evaluation in the monotherapy expansion component of the study, which is now under way.

"We are looking forward to sharing the full data from the completed monotherapy dose escalation component of our study later this week at the SITC (Free SITC Whitepaper) Annual Meeting. In addition to reporting on the safety and activity of IPI-549 monotherapy, for the first time we will present initial translational data from patients treated with IPI-549 as a monotherapy that can help us better understand how IPI-549 may activate an immune response," stated Adelene Perkins, Infinity’s chair and chief executive officer. "Patient enrollment in the monotherapy expansion component of the study is progressing very well, and we expect to initiate the combination expansion portion of the study by the end of this year, positioning us for data readouts from the monotherapy expansion cohort as well as data from the combination dose escalation and disease-specific expansion cohorts, all in the first half of 2018."

The Phase 1/1b study of IPI-549 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 200 patients with advanced solid tumors. The study includes four components: monotherapy dose escalation, combination therapy dose escalation, monotherapy expansion and combination expansion. The combination expansion 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 head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. Additionally, the combination expansion component will also evaluate a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy.

Based on progress made during 2017, Infinity expects to achieve the following IPI-549 data milestones in 2018:

Report data from the monotherapy expansion component of the study in the first half of 2018
Report data from the combination dose-escalation component of the study in the first half of 2018
Report initial data from the combination expansion component of the study in the first half of 2018, with more mature data from the combination expansion in the second half of 2018
"We are also focused on maintaining strong fiscal discipline and anticipate that we have cash runway into the first quarter of 2019, allowing us to generate safety and activity data on all four components of our Phase 1/1b study of IPI-549," commented Lawrence Bloch, M.D., J.D., president of Infinity. "We also have the potential to receive a future $22 million payment from Verastem upon the first regulatory approval of duvelisib, which we out-licensed in 2016, that could further strengthen our financial profile."

Recent Corporate Developments

$6.0 million payment received from Verastem: In October, Infinity received a $6.0 million cash payment from Verastem, Inc. The payment was made following the determination that the Phase 3 DUO clinical study evaluating the efficacy and safety of duvelisib in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma met certain pre-specified criteria at completion. Infinity out-licensed duvelisib to Verastem in November 2016.

Verastem recently provided guidance that it plans to submit a new drug application for duvelisib in the first quarter of 2018. Infinity is entitled to receive a $22 million payment from Verastem upon the first regulatory approval for duvelisib inside or outside the U.S.
Recent Clinical Developments

IPI-549 selected for an oral presentation at SITC (Free SITC Whitepaper) Annual Meeting: In October, Infinity announced that a late-breaking abstract describing new data for IPI-549 was selected for presentation during an oral session on new agents at the SITC (Free SITC Whitepaper) Annual Meeting. The abstract, "Monotherapy dose escalation clinical and translational data from first-in-human study in advanced solid tumors of IPI-549, an oral, selective, PI3K-gamma inhibitor targeting tumor macrophages" (Abstract O43), will be presented on Friday, November 10, 2017, from 2:15 p.m. – 2:30 p.m. ET. The lead author and presenter is David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX. An identically titled accompanying poster will also be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET.

Additionally, a clinical trials in progress poster, "Phase 1/1b, first-in-human study of the PI3K-gamma inhibitor IPI-549 as monotherapy and combined with nivolumab in patients with advanced solid tumors" (Abstract P219), will be presented on Friday, November 10, 2017, from 12:30 p.m. – 2:00 p.m. ET and 6:30 p.m. – 8:00 p.m. ET. The lead author on the poster is Antoni Ribas, M.D., Ph.D., Parker Institute Center Director at the University of California, Los Angeles (UCLA).

Infinity will host a reception for investors and analysts on Friday, November 10, 2017, from 6:00 a.m. to 8:00 a.m. ET to discuss the clinical development of IPI-549, including a review of data from the ongoing clinical study. The presentation portion of the reception will be webcast live beginning at 6:30 a.m. ET. The webcast and accompanying slides will be available in the "investors/media" section of the company’s website, www.infi.com. A replay of the event will also be available.
Expanded clinical collaboration with Bristol-Myers Squibb: In September, Infinity announced that it expanded its existing clinical collaboration with Bristol-Myers Squibb evaluating IPI-549 in combination with Opdivo to include patients with TNBC who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. The TNBC cohort will be part of the combination expansion component of the Phase 1/1b study.
Phase 1/1b study of IPI-549 advancing: The company is continuing to advance the Phase 1/1b study of IPI-549 both as a monotherapy and in combination with Opdivo in patients with solid tumors. Infinity has completed an evaluation of escalating monotherapy doses of IPI-549 ranging from 10 mg QD to 60 mg QD and selected the 60 mg dose for evaluation in the monotherapy expansion component of the study. Dose escalation evaluating IPI-549 40 mg QD in combination with Opdivo is ongoing, and Infinity expects to initiate the combination expansion component of the study by the end of 2017.
Third Quarter 2017 Financial Results

At September 30, 2017, Infinity had total cash, cash equivalents and available-for-sale securities of $55.6 million, compared to $66.2 million at June 30, 2017. The September 30, 2017 cash and investments balance excludes the $6.0 million payment from Verastem, which Infinity received in October 2017.
Revenue for the third quarter of 2017 was $6.0 million, all of which related to the amounts due from Verastem for the DUO study meeting the pre-specified criteria at completion. Infinity did not record any revenue during the third quarter of 2016.
Research and development (R&D) expense for the third quarter of 2017 was $9.3 million, compared to $12.8 million for the same period in 2016. The decrease in R&D expense was related to the company’s 2016 restructuring activities, partially offset by the $6.0 million convertible note issued to Takeda in exchange for eliminating Infinity’s royalty obligation to Takeda for selective inhibitors of PI3K gamma, including IPI-549.
General and administrative (G&A) expense was $4.5 million for the third quarter of 2017 compared to $7.1 million for the same period in 2016. The decrease in G&A expense was primarily due to the company’s 2016 restructuring activities.
Net loss for the third quarter of 2017 was $7.1 million, or a basic and diluted loss per common share of $0.14, compared to net loss of $19.5 million, or a basic and diluted loss per common share of $0.39, for the third quarter of 2016.
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 cash, cash equivalents and available-for-sale securities at September 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, November 7, 2017, at 8:30 a.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 97100725. 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, M2, to an anti-tumor, M1, phenotype and is able to overcome resistance to checkpoint inhibition as well as to enhance the activity of checkpoint inhibitors.1,2 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.

The ongoing Phase 1/1b study being conducted by Infinity is designed to evaluate the safety, tolerability, activity, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with Opdivo in approximately 200 patients with advanced solid tumors.3 The four-part study includes monotherapy and combination dose-escalation components, in addition to monotherapy expansion and combination expansion components. Patient enrollment is complete in monotherapy dose-escalation, and monotherapy expansion is ongoing. Combination dose-escalation is also ongoing, and combination expansion is expected to begin by the end of 2017.

The combination expansion component includes 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 head and neck squamous cell carcinoma (HNSCC) whose tumors show initial resistance or subsequently develop resistance to immune checkpoint blockade therapy. This combination expansion component will now also add a cohort of patients with triple negative breast cancer (TNBC) who have not been previously exposed to immune checkpoint blockade therapy. Although there has been great progress in the treatment of cancer, there remains a need for additional treatment options. NSCLC, melanoma, HNSCC and TNBC account for more than 22 percent of all new cancer cases in the U.S.4,5

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.