On May 4, 2017 Celsion Corporation (NASDAQ:CLSN) reported updated additional clinical and translational research data from its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with Stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (Press release, Celsion, MAY 4, 2017, View Source [SID1234518825]). Of the five evaluable patients in the first two cohorts who have been on the study for over one year, only one patient’s cancer has progressed after 11.7 months. This compares quite favorably to the historical median progression free survival (PFS) of 12 months for newly-diagnosed patients with Stage III and IV ovarian cancer who undergo neoadjuvant chemotherapy (NACT) followed by interval debulking surgery. Of the remaining four patients in the first two cohorts, their average PFS is 15.1 months with the longest progression-free patient at 19.1 months. None of the patients in the third or fourth dosing cohorts have progressed to date.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This new data on progression-free survival adds to the impressive clinical findings seen across a number of meaningful measures used to assess ovarian cancer like a 75% objective tumor response rate and a greater than 50% R0 (margin-negative) surgical resection rate," said Dr. Nicholas Borys, M.D., Celsion’s chief medical officer. "The consistency and robust nature of the data across all four cohorts and the encouraging clinical responses underscore the potential of GEN-1 to serve as an effective, safe IL-12 immunotherapy in ovarian cancer."

The Company also reported preliminary translational research findings from the first four patient cohorts. The analysis of peritoneal fluid and blood samples collected immediately before and 24 hours after IP administration of multiple doses of GEN-1 (36, 47, 61, 72 mg/m2) and standard NACT (carboplatin every 21 days and Taxol weekly) shows clear evidence of IL-12 gene transfer by significant dose dependent increases in IL-12 levels and immune system activity and significant increases in IFN-gamma and decreases in VEGF levels. The treatment-related changes in immune activating cytokines and pro-tumor VEGF levels followed a dose-dependent trend and were predominantly in the peritoneal fluid compartment with little to no changes observed in the patients’ systemic blood stream.

The immuno-histochemical (IHC) analysis of tumor tissue collected before treatment (laparoscopy) and after completion of eight GEN-1 weekly treatments showed increased infiltration of CD3+, CD4+ CD8+ T-cells into tumor tissue of several patients. The most pronounced effects observed in the IHC analysis were decreases in the density of immunosuppressive T-cell signals (FoxP3, PD-1, PDL-1, IDO-1) in the tumor microenvironment. The ratio of CD8+ cells to immunosuppressive cells was increased in 60-80% of patients suggesting an overall shift in the immune environment to pro-immune stimulatory following treatment with GEN-1.

"These translational research findings demonstrate that GEN-1 in ovarian cancer patients is biologically active and creates an immuno-stimulatory cytokine milieu in the peritoneal cavity in a dose-dependent manner and promotes a pro-immune T-cell population dynamics in the tumor micro-environment," said Dr. Khursheed Anwer, Celsion’s executive vice president and chief science officer. "These distinct immunological changes in local disease environment appear to translate into clinical benefit and warrant the continued development of our GEN-1 IL-12 immunotherapy as a potential adjuvant, in both first and second-line ovarian cancer."

On May 4, 2017– AVEO Oncology (NASDAQ:AVEO) reported financial results for the first quarter ended March 31, 2017, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We strengthened our balance sheet in the first quarter through an underwritten public offering, giving us the resources to potentially fund operations through the readout of our pivotal, Phase 3 TIVO-3 study of tivozanib in renal cell cancer (RCC), expected in the first quarter of 2018," said Michael Bailey, president and chief executive officer of AVEO. "TIVO-3, which is designed to serve as the basis for a potential U.S. registration of tivozanib as a first- and third-line treatment for RCC, remains on track to complete enrollment and a pre-planned interim futility analysis in June of this year. We also look forward to several other potential key milestones this year, including completion of the Phase 1 portion of the Phase 1/2 TiNivo trial a tivozanib-nivolumab combination study in RCC, a regulatory decision in Europe for marketing approval of tivozanib as a first line treatment for RCC, and notable progress in our pipeline programs."

Mr. Bailey continued: "Among our pipeline programs, we look forward to two planned ficlatuzumab data presentations from investigator sponsored studies at ASCO (Free ASCO Whitepaper), one in head and neck cancer and the other in acute myeloid leukemia. Ficlatuzumab, which targets Hepatocyte Growth Factor (HGF) with high affinity and specificity to inhibit HGF/c-Met biological activities, continues to attract investigator interest."

Recent Updates

Completion of the First Dose Cohort of the Phase 1/2 TiNivo Study of Tivozanib in Combination with Nivolumab in RCC. AVEO reported completion of the first dose cohort, and initiation of enrollment in the second and final dose cohort, of the Phase 1 portion of the Company’s Phase 1/2 TiNivo trial evaluating tivozanib in combination with Opdivo (nivolumab), Bristol-Myers Squibb’s anti-PD-1 therapy, in advanced RCC. The study, which is led by the Institut Gustave Roussy in Paris, is under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 portion of the study, which the Company expects to complete in the first half of 2017, will primarily evaluate the safety of tivozanib in combination with nivolumab at escalating doses of tivozanib. If the Company receives favorable results, it expects to follow immediately with an expansion Phase 2 trial at the established combination dose.
Presentation of Posters at Upcoming 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In April 2017, AVEO announced that poster presentations for three clinical studies will be presented at the upcoming 2017 ASCO (Free ASCO Whitepaper) Annual Meeting, to be held June 2-6, 2017. Among these are two presentations that highlight ficlatuzumab results from Phase 1 investigator-sponsored studies, one in head and neck squamous cell carcinoma and the other in acute myeloid leukemia. In addition, a Trials in Progress presentation will highlight the ongoing Phase 3, randomized, controlled, multi-center, open-label TIVO-3 study comparing tivozanib, the Company’s potent, selective, long half-life inhibitor of all three vascular endothelial growth factor (VEGF) receptors, to sorafenib in subjects with refractory advanced renal cell carcinoma.
Submission of Response to Tivozanib Marketing Authorization Application (MAA) Day 180 List of Outstanding Issues (LOI). In April 2017, AVEO announced that its European licensee for tivozanib, EUSA Pharma, submitted responses to the European Medicines Agency (EMA) Day 180 LOI related to the MAA for tivozanib as a first-line treatment for RCC. With submission of the response complete, EUSA remains tentatively scheduled to provide an oral explanation to the EMA’s Committee for Medicinal Products for Human Use at its May 2017 meeting.
Receipt of Milestone Payment from CANbridge for AV-203. In April 2017, AVEO announced receipt of a $500,000 milestone payment from CANbridge Life Sciences Ltd., a biopharmaceutical company focused on developing western drug candidates in China and North Asia, related to a technology transfer milestone for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate. CANbridge is planning clinical development of AV-203 in squamous cell esophageal cancer as its initial indication.
Closing of Public Offering and Full Exercise of Option to Purchase Additional Shares. In March 2017, AVEO announced the closing of an underwritten public offering of 34,500,000 shares of common stock, including the exercise in full by the underwriter of its option to purchase 4,500,000 shares at the public offering price of $0.50 per share. The net proceeds of the offering were approximately $15.5 million, and are expected to be used for working capital and general corporate purposes
TIVO-3 Enrolling Ahead of Schedule and Passes First Safety Monitoring Committee Safety Review; Pre-Planned Interim Futility Analysis Expected Midyear 2017. In February 2017, AVEO announced that its pivotal, Phase 3 TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC, successfully completed the first safety review by the study’s Safety Monitoring Committee (SMC). The SMC concluded that no safety concern was observed for tivozanib and recommended that the study replace the small number of patients who dropped out prior to starting treatment. The Company announced just prior to the safety review that the TIVO-3 trial is enrolling substantially ahead of schedule. With the SMC recommendation to replace early dropouts, the Company still expects to complete enrollment in June 2017, ahead of its prior guidance of August 2017. A pre-planned futility analysis of the trial is expected around midyear 2017, with topline data expected in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first-line treatment of RCC, is designed to support potential regulatory approval of tivozanib in the U.S. as a third- and first- line treatment for RCC.
Personnel Updates

AVEO also announced today that Keith S. Ehrlich, the Company’s Chief Financial Officer, will be retiring from the Company, effective July 1, 2017. The Company has initiated a search for a new chief financial officer. Michael Bailey, the Company’s President and CEO, will assume certain of Mr. Ehrlich’s duties on an interim basis, to the extent a new chief financial officer has not been named by the time of Mr. Ehrlich’s retirement.

Mr. Bailey added: "We greatly appreciate Keith’s contributions to AVEO and wish him well in his future endeavors. His leadership and guidance through a period of turnaround for the Company have been greatly valued. We look forward to a completing the search for a new chief financial officer as expeditiously as possible."

First Quarter 2017 Financial Highlights

AVEO ended Q1 2017 with $33.4 million in cash, cash equivalents and marketable securities as compared with $23.3 million at December 31, 2016.
Total collaboration revenue for Q1 2017 was approximately $2.5 million compared with $1.2 million for Q1 2016.
Research and development expense for Q1 2017 was $8.0 million compared with $6.0 million for Q1 2016.
General and administrative expenses for Q1 2017 was $2.3 million compared with $2.5 for Q1 2016.
Net loss for Q1 2017 was $8.8 million, or a loss of $0.12 per basic and diluted share compared with net loss of $7.7 million or a loss of $0.13 per basic and diluted share for Q1 2016.
Updated Financial Guidance

We believe that our $33.4 million in cash resources would allow us to fund our planned operations into the second quarter of 2018.

On May 4, 2017 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the first quarter ended March 31, 2017 (Press release, Agios Pharmaceuticals, MAY 4, 2017, View Source [SID1234518817]). In addition, Agios highlighted select corporate milestones and data presentations for its preclinical and clinical development programs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our team made significant progress during the first quarter advancing our late-stage pipeline and preparing for the first product launch from our research and discovery engine, which is an important milestone for our organization," said David Schenkein, M.D., chief executive officer at Agios. "We are on track to execute against our remaining key 2017 goals, including finalizing the design of our global pivotal program for AG-348 in PK deficiency in the third quarter and submitting both an NDA for ivosidenib in R/R AML and our sixth IND, for AG-270, a development candidate focused on MTAP-deleted tumors, by the end of the year."

FIRST QUARTER 2017 HIGHLIGHTS & RECENT PROGRESS

IDH Mutant Inhibitors:

A New Drug Application (NDA) was filed with the U.S. Food and Drug Administration (FDA) for IDHIFA (enasidenib) in relapsed and/or refractory (R/R) acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation; the NDA was granted Priority Review and has been given a Prescription Drug User Fee Act (PDUFA) action date of August 30, 2017.
Completed enrollment of the 125-patient expansion cohort for the Phase 1 trial of ivosidenib in patients with IDH1m positive R/R AML.
On April 26, 2017, the FDA granted ivosidenib Orphan Drug Designation for the treatment of cholangiocarcinoma.
Rare Genetic Diseases:

On April 27, 2017, the FDA granted AG-348 Fast Track Designation for the treatment of patients with pyruvate kinase (PK) deficiency. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Completed enrollment of 258 patients in the PK deficiency Natural History Study being conducted with Boston Children’s Hospital.
Research:

Presented preclinical data on molecules with potential for the treatment of methylthioadenosine phosphorylase (MTAP) deleted tumors, at the Keystone Tumor Metabolism Meeting in Whistler, British Columbia.
Celgene designated AG-270 for the treatment of MTAP-deleted cancers as a development candidate under the master research and collaboration agreement dated May 17, 2016, triggering an $8 million milestone payment to Agios.
In April, Agios and Aurigene Discovery Technologies Limited entered into a global license agreement to research, develop and commercialize small molecule inhibitors of an undisclosed cancer metabolism target.
Corporate:

Also in April, Agios completed an underwritten public offering of 5,808,080 shares of common stock, which includes the full exercise of the underwriters’ option to purchase an additional 757,575 shares, at the offering price of $49.50 per share, resulting in proceeds, net of underwriting discounts and commissions, of approximately $270.2 million.
ANTICIPATED 2017 DATA PRESENTATIONS

Updated data from the Phase 1/2 trial evaluating IDHIFA (enasidenib) in patients with IDH2m positive R/R AML at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 2-6, 2017 in Chicago
First data from the cholangiocarcinoma expansion cohort of the ongoing Phase 1 trial of ivosidenib in advanced IDH1m positive solid tumors at ASCO (Free ASCO Whitepaper)
Updated data from the AG-348 Phase 2 DRIVE PK trial in PK deficiency at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 22-25, 2017 in Madrid, Spain
Updated data from DRIVE PK, including longer follow-up and secondary analyses, and updated data from the PK deficiency Natural History Study in the second half of 2017
First data from the expansion phase of the ongoing Phase 1 trial of ivosidenib in R/R AML in the second half of 2017
First data from the ongoing Phase 1b combination trial of IDHIFA (enasidenib) or ivosidenib with standard-of-care intensive chemotherapy in newly diagnosed AML in the second half of 2017
Updated data from the glioma expansion cohort of the ongoing Phase 1 trial of ivosidenib in advanced IDH1m positive solid tumors in the second half of 2017
KEY UPCOMING MILESTONES

IDH Mutant Inhibitors in Hematologic Malignancies

Potential approval and co-commercialization of IDHIFA (enasidenib) in the U.S. for IDH2m positive R/R AML in collaboration with Celgene with a PDUFA action date of August 30, 2017.
Initiate a global, registration-enabling Phase 3 study (AGILE) combining ivosidenib and VIDAZA in newly diagnosed AML patients with an IDH1 mutation ineligible for intensive chemotherapy in the first half of 2017.
Submit an NDA to the U.S. FDA for ivosidenib for IDH1m positive R/R AML by the end of 2017.
IDH Mutant Inhibitors in Solid Tumors

Complete enrollment of the dose-escalation phase of the ongoing Phase 1 study of AG-881 in IDHm positive glioma in the first half of 2017.
Rare Genetic Diseases

Finalize design for a global pivotal trial of AG-348 in PK deficiency in the third quarter of 2017.
Initiate a global pivotal trial of AG-348 in PK deficiency in the first half of 2018.
Research:

Submit an Investigational New Drug (IND) application for AG-270, the development candidate targeting MTAP-deleted tumors, by the end of 2017.
FIRST QUARTER 2017 FINANCIAL RESULTS

Collaboration revenue was $10.5 million for the quarter ended March 31, 2017, compared to $31.3 million for the comparable period in 2016. The decrease in revenue was primarily due to the fact that in the first quarter of 2016, the company recognized a $25 million milestone payment related to the initiation of the Phase 3 IDHENTIFY trial of IDHIFA (enasidenib).

Research and development (R&D) expense was $62.7 million, including $7.0 million of stock-based compensation expense, for the quarter ended March 31, 2017, compared to $44.0 million, including $5.5 million of stock-based compensation expense, for the quarter ended March 31, 2016. The increase in R&D expense was primarily due to increased costs to support advancement of the company’s lead investigational medicines toward later-stage development. Celgene is responsible for all development costs for IDHIFA (enasidenib) and certain development costs for AG-881, and reimburses Agios for development costs incurred for these investigational medicines. In addition, Celgene was responsible for approximately half of development costs for ivosidenib during the quarter ended March 31, 2016. As of August 2016, Agios is responsible for all ivosidenib development costs.

General and administrative (G&A) expense was $14.8 million, including $3.7 million of stock-based compensation expense, for the quarter ended March 31, 2017, compared to $10.8 million, including $3.6 million of stock-based compensation expense, for the quarter ended March 31, 2016. The increase in G&A expense was largely due to increased headcount and additional expenses to support our growing commercial organization.

Net loss for the quarter ended March 31, 2017 was $66.2 million, compared to a net loss of $23.2 million for the quarter ended March 31, 2016.

Cash & Cash Guidance

Cash, cash equivalents and marketable securities as of March 31, 2017 were $503.2 million, compared to $573.6 million as of December 31, 2016. The decrease in cash was driven by expenditures to fund operations of $79.4 million during the quarter ended March 31, 2017. These items were offset by an increase in cash of $5.0 million of program funding received under our collaboration agreements with Celgene and $4.1 million received from employee stock award transactions.

In April, Agios completed an underwritten public offering of 5,808,080 shares of common stock, which includes the full exercise of the underwriters’ option to purchase an additional 757,575 shares, at the offering price of $49.50 per share, resulting in proceeds, net of underwriting discounts and commissions, of approximately $270.2 million.

The company expects that its cash, cash equivalents and marketable securities as of March 31, 2017, together with the net proceeds from the recent financing, anticipated interest income, and anticipated payments under our collaboration agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2019.

On May 4, 2017 Incyte Corporation (Nasdaq: INCY) reported 2017 first-quarter financial results, highlighting strong revenue growth driven by increased sales of Jakafi (ruxolitinib) in the U.S. and Iclusig (ponatinib) in Europe, and royalties from ex-U.S. sales of Jakavi (ruxolitinib) by Novartis; and now including royalties from European sales of Olumiant (baricitinib) by Lilly (Press release, Incyte, MAY 4, 2017, View Source [SID1234518842]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Incyte continues to expand its development portfolio. The pivotal program studying ruxolitinib in patients with graft-versus-host disease (GVHD) is underway, and the pivotal program studying ruxolitinib in patients with essential thrombocythemia (ET) is expected to start soon. The Company recently announced details of its expanded collaboration with Merck, growing the pivotal program studying epacadostat in combination with pembrolizumab to a total of five tumor types. Additionally, Incyte expanded its collaboration with Bristol-Myers Squibb evaluating epacadostat in combination with nivolumab in pivotal studies in two tumor types. Data recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting showcased the clinical profile of Incyte’s selective FGFR1/2/3 inhibitor which is now in Phase 2 trials in three indications and which, if successful, may be registration-enabling.
"The strong growth of Jakafi is very exciting as we continue to see more patients benefiting from treatment in both approved indications," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We believe that our clinical portfolio is progressing well, with epacadostat moving rapidly into multiple pivotal programs and numerous other programs in or planned to enter potentially registration-enabling studies."
Portfolio Update
Cancer – Targeted Therapies
In March, the first patient entered REACH2, the Novartis-sponsored randomized Phase 3 trial of ruxolitinib for the treatment of patients with steroid-refractory acute GVHD. REACH3, a Phase 3 trial of ruxolitinib as a treatment for patients with steroid-refractory chronic GVHD, is expected to begin in 2017. REACH3 is to be conducted in collaboration with Novartis.
In February, the first patient was dosed in the Phase 2 CITADEL-202 trial, studying the selective PI3Kδ inhibitor INCB50465 as monotherapy in patients with diffuse large B-cell lymphoma (DLBCL).
In April, initial clinical data from INCB54828, Incyte’s selective FGFR1/2/3 inhibitor, was presented at the 2017 AACR (Free AACR Whitepaper) meeting, including safety and efficacy in patients with bladder cancer, cholangiocarcinoma and 8p11 MPNs.

Indication Status Update
Ruxolitinib (JAK1/JAK2) Steroid-refractory acute GVHD Pivotal Phase 2 (REACH1) and Phase 3 (REACH2) underway
Ruxolitinib (JAK1/JAK2) Steroid-refractory chronic GVHD Phase 3 (REACH3) expected to begin in 2017
Ruxolitinib (JAK1/JAK2) Essential thrombocythemia Pivotal program expected to begin in 2017
Itacitinib (JAK1) Treatment-naïve acute GVHD Pivotal program expected to begin in 2017
Itacitinib (JAK1) Non-small cell lung cancer Phase 1/2 in combination with osimertinib (EGFR)
INCB52793 (JAK1) Advanced malignancies Phase 1/2 dose-escalation
INCB50465 (PI3Kδ) Diffuse large B-cell lymphoma Phase 2 (CITADEL-202)
INCB54828 (FGFR1/2/3)
Bladder cancer, cholangiocarcinoma; 8p11 MPNs
Phase 2 (FIGHT-201, FIGHT-202, FIGHT-203)
INCB54329 (BRD) Advanced malignancies Phase 1/2 dose-escalation
INCB57643 (BRD) Advanced malignancies Phase 1/2 dose-escalation
INCB53914 (PIM) Advanced malignancies Phase 1/2 dose-escalation
INCB59872 (LSD1) Acute myeloid leukemia, small cell lung cancer Phase 1/2 dose-escalation
INCB62079 (FGFR4) Hepatocellular carcinoma Phase 1/2 dose-escalation expected to begin in 2017

Cancer – Immune Therapies
In March 2017, Incyte and Merck announced the details of the expanded clinical development program investigating epacadostat with pembrolizumab. Incyte and Merck will move into pivotal programs in four additional tumor types beyond melanoma – non-small cell lung cancer (NSCLC), bladder, renal, and head & neck cancers – across six Phase 3 trials. These trials are expected to begin in 2017.
In April 2017, Incyte and Bristol-Myers Squibb announced an expanded collaborative clinical development program investigating epacadostat with nivolumab in pivotal programs for both NSCLC and head & neck cancer. Phase 3 trials are expected to begin in 2017.

Indication Status Update
Epacadostat (IDO1) Unresectable or metastatic melanoma Phase 3 (ECHO-301) in combination with pembrolizumab (PD-1)
Epacadostat (IDO1) NSCLC, renal, bladder and head & neck cancer Phase 3 in combination with pembrolizumab (PD-1) expected to begin in 2017
Epacadostat (IDO1) NSCLC, head & neck cancer Phase 3 in combination with nivolumab (PD-1) expected to begin in 2017
Epacadostat (IDO1) Multiple tumor types Phase 2 (ECHO-202) expansion cohorts in combination with pembrolizumab (PD-1)
Epacadostat (IDO1) Multiple tumor types Phase 2 (ECHO-204) expansion cohorts in combination with nivolumab (PD-1)
Epacadostat (IDO1) Multiple tumor types Phase 2 (ECHO-203) expansion cohorts in combination with durvalumab (PD-L1)
Epacadostat (IDO1) NSCLC, bladder cancer Phase 1/2 (ECHO-110) dose-escalation in combination with atezolizumab (PD-L1)
INCB01158 (ARG)1 Solid tumors Phase 1/2 dose-escalation
INCSHR1210 (PD-1)2 Solid tumors Phase 1/2 dose-escalation completed; enrollment suspended
INCAGN1876 (GITR)3 Solid tumors Phase 1/2 dose-escalation
INCAGN1949 (OX40)3 Solid tumors Phase 1/2 dose-escalation
PD-1 platform study Solid tumors Phase 1/2, pembrolizumab (PD-1) in combination with itacitinib (JAK1) or INCB50465 (PI3Kδ)
JAK1 platform study Solid tumors
Phase 1/2, itacitinib (JAK1) in combination with epacadostat (IDO1) or INCB50465 (PI3Kδ)
Notes:
1) INCB01158 co-developed with Calithera
2) INCSHR1210 licensed from Hengrui
3) INCAGN1876 & INCAGN1949 from discovery alliance with Agenus

Non-oncology
In January, Incyte initiated a Phase 2 trial of topical ruxolitinib for the treatment of patients with atopic dermatitis, and a Phase 2 trial in patients with vitiligo is expected to begin in 2017. After 24 weeks of treatment, Incyte has determined that data from the recently-completed randomized Phase 2 trial of topical ruxolitinib in patients with alopecia areata do not justify progression of the program into pivotal studies.

Indication Status Update
Topical ruxolitinib (JAK1/JAK2) Atopic dermatitis Phase 2
Topical ruxolitinib (JAK1/JAK2) Vitiligo Phase 2 expected to begin in 2017

Partnered
In February 2017, the European Commission approved Olumiant (baricitinib) for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
In April 2017, the FDA issued a complete response letter (CRL) for baricitinib in which the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. Incyte and Lilly disagree with the agency’s conclusions and Incyte currently expects that Lilly will now engage with the FDA to discuss the agency’s concerns and determine a potential path forward.
Novartis anticipates submitting an NDA for capmatinib, Incyte’s potent and selective c-MET inhibitor, in 2018.

Indication Status Update
Baricitinib (JAK1/JAK2)1 Rheumatoid arthritis Approved in Europe; CRL issued by FDA
Baricitinib (JAK1/JAK2)1 Psoriatic arthritis Lilly expects Phase 3 to begin in 2017
Baricitinib (JAK1/JAK2)1 Atopic dermatitis, systemic lupus erythematosus Phase 2
Capmatinib (c-MET)2 Non-small cell lung cancer, liver cancer Phase 2 in EGFR wild-type ALK negative NSCLC patients with c-MET amplification and mutation
Notes:
1) Baricitinib licensed to Lilly
2) Capmatinib licensed to Novartis

2017 First-Quarter Financial Results
Revenues For the quarter ended March 31, 2017, net product revenues of Jakafi were $251 million as compared to $183 million for the same period in 2016, representing 37 percent growth. For the quarter ended March 31, 2017, net product revenues of Iclusig were $14 million1.
For the quarter ended March 31, 2017, product royalties from sales of Jakavi outside of the United States received from Novartis were $29 million as compared to $22 million for the same period in 2016. For the quarter ended March 31, 2017, product royalties from sales of Olumiant outside of the United States received from Lilly were $0.4 million.
For the quarter ended March 31, 2017, contract revenues were $90 million as compared to $58 million for the same period in 2016. The increase in contract revenues relates to milestone payments earned.
For the quarter ended March 31, 2017, total revenues were $384 million as compared to $263 million for the same period in 2016.

Year Over Year Revenue Growth
(in thousands, unaudited)

Three Months Ended
March 31, %
2017 2016 Change
Revenues:
Jakafi net product revenue $ 251,077 $ 183,267 37 %
Iclusig net product revenue 13,730 - -
Product royalty revenues 29,221 21,903 33 %
Contract revenues 90,000 58,214 -
Other revenues 54 80 -
Total revenues $ 384,082 $ 263,464 46 %

Research and development expenses Research and development expenses for the quarter ended March 31, 2017 were $408 million as compared to $157 million for the same period in 2016. Included in research and development expenses for the quarter ended March 31, 2017 were non-cash expenses related to equity awards to our employees of $22 million. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio as well as upfront and milestone expenses of $209 million related to our collaboration and license agreements with Agenus, Calithera and Merus.
Selling, general and administrative expenses Selling, general and administrative expenses for the quarter ended March 31, 2017 were $87 million as compared to $65 million for the same period in 2016. Included in selling, general and administrative expenses for the quarter ended March 31, 2017 were non-cash expenses related to equity awards to our employees of $9 million. Increased selling, general and administrative expenses are driven primarily by additional costs related to the commercialization of Jakafi and the geographic expansion in Europe.
Change in fair value of acquisition-related contingent consideration The change in fair value of acquisition-related contingent consideration of $7 million for the quarter ended March 31, 2017 represents the fair market value adjustments of the Company’s contingent liability related to the acquisition of the European business of ARIAD Pharmaceuticals, Inc.
Unrealized loss on long term investments Unrealized loss on long term investments for the quarter ended March 31, 2017 were $6 million as compared to $3 million for the same period in 2016. The unrealized loss on long term investments for the quarter ended March 31, 2017 represents the fair market value adjustments of the Company’s investments in Agenus and Merus.
Expense related to senior note conversions Expense related to senior note conversions for the quarter ended March 31, 2017 was $54 million related to the conversions of our 2018 and 2020 convertible senior notes.
Net income (loss) Net loss for the quarter ended March 31, 2017 was $187 million, or $0.96 per basic and diluted share, as compared to net income of $24 million, or $0.13 per basic and $0.12 per diluted share for the same period in 2016.
Cash, cash equivalents and marketable securities position As of March 31, 2017, cash, cash equivalents and marketable securities totaled $512 million as compared to $809 million as of December 31, 2016.
2017 Financial Guidance
The Company has updated its full year 2017 financial guidance, as detailed below.

Current Previous
Jakafi net product revenues $1,020-$1,070 million Unchanged
Iclusig net product revenues $60-$65 million Unchanged
Research and development expenses* $1,000-$1,100 million $990-$1,040 million
Selling, general and administrative expenses $340-$360 million Unchanged
Change in fair value of acquisition-related contingent consideration $30-$35 million Unchanged
* Includes upfront and milestone expenses of $209 million related to the amended Agenus collaboration, and the Merus and Calithera collaborations