On November 9, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported preliminary data from its ongoing Phase 1 dose-escalation study of AB122 (Press release, Arcus Biosciences, NOV 9, 2018, View Source [SID1234531103]). The data are being presented today during a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington, D.C.

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"Preclinical data previously demonstrated that AB122 has biological, pharmacokinetic and pharmacodynamic properties similar to those of the approved anti-PD-1 antibodies and the dose-escalation data presented today represent an important step in confirming these results in patients," said Joyson Karakunnel, MD, MSc, FACP, Vice President of Clinical Development at Arcus. "These results support the selection of 240 mg as the AB122 dose for administration every 2 weeks (Q2W); we continue to enroll patients in the Phase 1 study to identify the appropriate doses for administration every 3 weeks (Q3W) or every 4 weeks (Q4W)."

"Since Arcus’s inception, we believed it was important to ensure access to an anti-PD-1 antibody to maximize the value of our internally discovered product candidates, which guided our decision to in-license AB122 from WuXi Biologics, one of the leading biologics manufacturing companies," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "Our development strategy for AB122 is focused on its development in combination with our other product candidates, including AB928, our dual adenosine receptor antagonist, AB680, our small molecule CD73 inhibitor, and AB154, our anti-TIGIT antibody."

Design of the Phase 1 Dose-Escalation Study for AB122

The Phase 1 dose-escalation study for AB122 is designed to evaluate the safety, immunogenicity, pharmacokinetic, pharmacodynamic and clinical activity profile of AB122. The Company is evaluating three dosing regimens with the goal of identifying doses of AB122 that can be administered Q2W, Q3W or Q4W.

As of the cutoff date of October 5, 2018, 20 patients had been treated:

For the Q2W dosing regimen, doses of 80 mg (n=3), 240 mg (n=6), and 360 mg (n=1) were evaluated. 240 mg was identified as the recommended dose for this regimen, based on receptor occupancy data.
For the Q3W dosing regimen, a dose of 360 mg (n=5) is being evaluated. This cohort continues to enroll patients with the goal of identifying a recommended dose for this regimen.
For the Q4W dosing regimen, a dose of 480 mg (n=5) is being evaluated. This cohort also continues to enroll patients with the goal of identifying a recommended dose for this regimen.
Results from the Phase 1 Dose-Escalation Study

As of the data cutoff date:

The following tumor types were enrolled: ovarian (7), colorectal (3), endometrial (3), gastroesophageal (2), bladder (1), head and neck (1), breast (1), non-small cell lung (1), and prostate (1).
Time on study ranged from 0.8 to 9.9 months.
AB122 was well tolerated at all doses evaluated. The majority of treatment emergent adverse events (TEAEs), regardless of causality in all subjects, were Grade 1/2, the most common of which were fatigue (55%) and diarrhea and nausea (25% each). Three patients experienced serious adverse events (SAEs), none of which were considered related to AB122: Grade 2 lower respiratory tract infection, Grade 2 fever and Grade 3 elevated liver function tests secondary to cholelithiasis.
Data from the three patients in the 80 mg Q2W and six patients in the 240 mg Q2W cohorts showed that AB122 achieved full and sustained receptor occupancy on peripheral blood T cells across all time points in the majority of patients. These data are consistent with published data for approved anti-PD-1 antibodies.
Of the 16 response-evaluable patients, two patients demonstrated a reduction in tumor size: a patient with head and neck cancer in the 80 mg Q2W cohort and a patient with ovarian cancer in the 360 mg Q2W cohort.
Disease control rate was 50% in the evaluable patient population. Stable disease was achieved in patients with colorectal cancer (2), ovarian cancer (1) and head and neck cancer (1).
Ongoing and Planned Clinical Trials for AB122

Arcus is planning to initiate an expansion cohort which will evaluate AB122 in non-small cell lung cancer with the objective of confirming that AB122 has similar clinical activity to that of the approved PD-1 antibodies. AB122 is also being evaluated in combination with AB928, as well as with AB154, in Phase 1/1b dose-escalation trials.

Details of Arcus’s Poster Presentation is as Follows:

Title: Preliminary results from an ongoing Phase 1 study of AB122, an anti-programmed cell death-1 (PD-1) monoclonal antibody, in patients with advanced solid tumors.
Poster Number: P673; Abstract ID: 10638
Poster Presentation Hours: Friday, Nov. 9, from 12:45 – 2:15 pm and 6:30 – 8 pm ET
Poster Hall Location: Hall E

This poster presentation, as well as the Company’s eight other posters being presented at SITC (Free SITC Whitepaper), will be available on Arcus’s corporate website at View Source

About AB122

AB122 is a fully human IgG4 antibody that potently and selectively blocks the interaction of PD-1 with its ligands, PD-L1 and PD-L2. The biochemical, biological and preclinical properties of AB122 have been shown to be similar to those of the marketed anti-PD-1 antibodies nivolumab and pembrolizumab. In August 2017, Arcus entered into a license agreement with WuXi Biologics for an exclusive license to develop, use, manufacture, and commercialize AB122 worldwide except for China and five other countries outside of the U.S., Europe and Japan. In November 2017, dosing was initiated in Australia for the Phase 1 trial of AB122 in cancer patients. AB122 is also being evaluated in combination with AB928, the Company’s dual adenosine receptor antagonist, in a Phase 1/1b dose-escalation trial. Preliminary data from this trial are expected in the second quarter of 2019. The Company expects AB122 to form the backbone of many of its intra-portfolio combinations.

On November 9, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that data from three separate trials are being presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in Washington D.C (Press release, NewLink Genetics, NOV 9, 2018, View Source [SID1234531173]). Data from a Phase 1a clinical trial of NLG802, a prodrug of indoximod, as well as biomarker data from two Phase 2 studies of indoximod in combination therapy are being presented in poster sessions today and tomorrow, November 9th and 10th, from 8:00AM to 8:00PM ET. These posters with full data sets are provided on the company’s website in the "Posters & Presentations" section under the "Investors & Media" tab.

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"We are delighted to be able to present these data supporting both activity of indoximod within the tumor microenvironment and the higher exposure levels obtained by indoximod prodrug, NLG802, supporting the potential for these drugs to elicit therapeutic responses and improve the lives of patients with cancer," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.

Phase 1 Clinical Trial of NLG802, Indoximod Prodrug with Enhanced Pharmacokinetic Properties
Preliminary data from a Phase 1a study of NLG802, a prodrug of indoximod, are being presented today by Olivier Rixe, MD, PhD, Professor of Medicine, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM in a poster session (P331). Co-author, Eugene Kennedy, MD, Chief Medical Officer, NewLink Genetics, will be present Friday, November 9th, 12:45-2:15PM and 6:30-8:00PM, to discuss these data.

NLG802 is being evaluated in an ongoing standard 3+3 dose escalation Phase 1a study in patients with recurrent advanced solid malignancies. The purpose of this trial is to assess the safety, maximum tolerated dose, and pharmacokinetic properties of this drug candidate. As of October 3rd, the cutoff date for these data, 11 patients were enrolled in this study in three separate dose cohorts, 180 mg BID, 363 mg BID, and 726 mg BID.
Key findings from these preliminary data:

NLG802, was well tolerated, with no unexpected safety signals.

At the time of analysis, neither maximum tolerated dose (MTD), nor maximum biologically achievable dose (MBAD) had been reached.

NLG802 produced 4-fold increase in CMAX and AUC after a single dose, and a 4-5.5 fold increases in CMAX and AUC after continuous BID dosing compared with the molar equivalent of indoximod dosing.

The Immunogenic Impact of Indoximod on the Tumor Microenvironment of Patients with Advanced Melanoma
Biopsy data from a Phase 2 study of indoximod plus checkpoint inhibition from patients with advanced melanoma are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session (P142). The author will be present Saturday, November 10th, 12:20-1:50PM and 7:00-8:30PM to discuss these data.
In this study, patients with unresectable advanced melanoma underwent pretreatment tumor biopsy followed by a repeat biopsy after cycle 3 of indoximod plus pembrolizumab. Fourteen pairs of tumor specimens (6 patients with objective response and 8 non-responders) underwent RNA sequencing analysis and immunofluorescence staining to
assess immune activity in the tumor microenvironment (TME), to define changes in the tumor genomic profile and gene expression. Baseline samples from the trial were used for predictive biomarker assessment (N = 38).
Key findings from these biopsy data:

Compared to published studies, these biopsy data suggested indoximod exclusively contributed to immunologic and metabolic changes in the TME.

Indoximod in combination therapy may contribute to immunologic and metabolic changes in a different manner than anti-PD-1 alone.

Decreased IDO1 in Ki67- cells supports indoximod’s mechanism of action (MOA).

Patients with high IDO expression showed a trend towards both higher rate of response to treatment and longer progression-free survival (PFS), results which were independent of PD-L1 expression.

Previously published results from this Phase 2 study of indoximod plus pembrolizumab for patients with advanced melanoma may be found on the company’s website under "Posters & Publications" in the "Investors & Media" section.
Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreas cancer
Biopsy data from a Phase 2 study of indoximod plus chemotherapy for patients with metastatic pancreatic cancer are being presented today by Jiayi Yu, PhD, Senior Scientist, NewLink Genetics, in a poster session (P706). Co-author, Gabriela Rossi, PhD, Vice President, Biologics Development, NewLink Genetics, will be present Saturday, November 10th, 12:20-1:50PM and 7:00-8:30PM to discuss these data.
In this study, treatment-naïve patients with metastatic pancreatic cancer underwent pre-treatment tumor biopsy with a repeat biopsy on week 8. Sixteen pairs of tumor specimens (8 patients with objective response, and 8 non-responders) underwent RNA sequencing analysis and immunohistochemistry (IHC) staining to assess immune activity in the tumor microenvironment.
Key findings from these biopsy data indicate that indoximod plus standard-of-care (SOC) chemotherapy:

Tumor samples observed to have increased recruitment of intratumoral T cells.

Increased recruitment of innate immune cells (NK cells) in responding patients.

Downregulated Treg population and IDO expression in the TME.

Increased both innate and adaptive immune responses in TME of these patients, supporting indoximod’s MOA.

Previously published results from this Phase 2 study of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer may be found on the company’s website under "Posters & Publications" in the "Investors & Media" section.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

About NLG802

NLG802 is a prodrug of indoximod. NLG802 has been shown in preclinical trials to increase bioavailability and exposure to indoximod above the levels achievable by direct administration of indoximod. NLG802 is currently being evaluated in clinical trials.

On November 9, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference during November and invited investors to participate by webcast (Press release, Exact Sciences, NOV 9, 2018, View Source [SID1234531189]).

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Jefferies 2018 London Healthcare Conference, London
Presentation and Q&A session on Thursday, Nov. 15 at 2:40 p.m. GMT, 9:40 a.m. EST
Evercore ISI HealthconX, Boston
Fireside chat on Tuesday, Nov. 27 at 12:30 p.m. EST

On November 9, 2018 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, reported financial results and recent corporate highlights for the third quarter ended September 30, 2018 (Press release, Fortress Biotech, NOV 9, 2018, View Source [SID1234531206]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress and our subsidiaries continued to achieve important corporate and clinical milestones in the third quarter of 2018. Mustang Bio expanded its pipeline into gene therapy by securing an exclusive worldwide license for the development of a potentially first-in-class ex vivo lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency ("X-SCID") from St. Jude Children’s Research Hospital ("St. Jude"). Additionally, Checkpoint Therapeutics announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor ("EGFR") inhibitor being evaluated in advanced non-small cell lung cancer ("NSCLC"). Finally, Cyprium Therapeutics’ product candidate for patients diagnosed with classic Menkes disease, CUTX-101, was granted Fast Track Designation by the U.S. Food and Drug Administration ("FDA"). We plan to continue to acquire and develop compelling and, in some instances, potentially life-saving product candidates, which could lead to maximizing shareholder value."

Financial Results:

· As of September 30, 2018, Fortress’ consolidated cash, cash equivalents, short-term investments (certificates of deposit), cash deposits with clearing organizations and restricted cash totaled $136.1 million, compared to $168.3 million as of December 31, 2017, a decrease of $32.2 million year-to-date.
· Net revenue totaled $63.7 million for the third quarter of 2018, compared to $46.9 million for the third quarter of 2017. Total revenue as of September 30, 2018 includes $5.2 million of Fortress revenue, primarily from the sale of Journey Medical Corporation products, and $58.5 million of revenue from National Holdings Corporation1 ("National Holdings"). Total revenue as of September 30, 2017 included $2.5 million of Fortress revenue and $44.4 million of revenue from National Holdings.
· Research and development expenses were $16.1 million for the third quarter of 2018, of which $15.1 million was related to Fortress Companies. This compares to $15.9 million for the third quarter of 2017, of which $14.2 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in research and development were $1.8 million for the third quarter of 2018, compared to $1.6 million for the third quarter of 2017.
· Research and development expenses from license acquisitions were $3.7 million for the third quarter of 2018, compared to $0.3 million for the third quarter of 2017.
· General and administrative expenses were $12.2 million for the third quarter of 2018, of which $7.4 million was related to Fortress Companies. This compares to $15.1 million for the third quarter of 2017, of which $10.5 million was related to Fortress Companies. Non-cash, stock-based compensation expenses included in general and administrative expenses were $2.3 million for the third quarter of 2018, compared to $2.6 million for the third quarter of 2017.
· National Holdings’ operating expenses totaled $55.2 million for the third quarter of 2018, compared to $47.7 million for the third quarter of 2017.
· Net loss attributable to common stockholders was $16.6 million, or $0.37 per share, for the third quarter of 2018, compared to a net loss attributable to common stockholders of $27.1 million, or $0.67 per share, for the third quarter of 2017. For the first nine months of 2018, net loss attributable to common stockholders was $59.3 million or $1.36 per share, compared to $56.5 million or $1.39 per share in the first nine months of 2017.

On November 9, 2018 AVEO Oncology (NASDAQ: AVEO) reported financial results for the third quarter ended September 30, 2018 and provided a business update (Press release, AVEO, NOV 9, 2018, View Source [SID1234530993]).

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"The recent announcement of positive topline results from the Phase 3 TIVO-3 study in renal cell carcinoma is transformative for AVEO, and the next step of an ongoing, multi-year effort to ensure tivozanib (FOTIVDA) is available to patients for whom it could deliver its differentiated combination of efficacy and tolerability relative to other commercially available TKIs in RCC," said Michael Bailey, president and chief executive officer of AVEO. "We remain committed to our three-pillar strategy for tivozanib, which includes potential registration in the U.S., the ongoing commercialization of FOTIVDA in Europe with partner EUSA Pharma, and a broad exploration of tivozanib’s potential in combination with immunotherapies in cancer. Our recent achievements with TIVO-3 also provides a strong foundation to realize the potential of our pipeline, which includes two oncology-focused product candidates and three non-oncology product candidates."

Tivozanib TIVO-3 Study North America Update

Positive Topline Results from Phase 3 TIVO-3 Trial of Tivozanib in Renal Cell Carcinoma, with Goal to Submit NDA in Approximately Six Months. On Monday, November 5, 2018, AVEO announced positive topline results from the primary analysis of the TIVO-3 trial, the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in 351 subjects with refractory advanced or metastatic renal cell carcinoma (RCC). The trial met its primary endpoint of demonstrating a statistically significant benefit in progression-free survival (PFS). Patients receiving tivozanib demonstrated a 44% improvement in median PFS and a 26% reduction in risk of progression or death (hazard ratio (HR)=0.74; p=0.02). Preliminary overall survival (OS) at the time of the final PFS analysis was immature (only 46% of events reported) and showed no statistically significant difference (HR=1.06, p=0.69). 149 patients remain on treatment or in long term follow-up.

Tivozanib was generally well-tolerated, with adverse events consistent with those observed in previous tivozanib trials, including the Phase 3 TIVO-1 trial in front-line RCC. The most common adverse event in patients receiving tivozanib was hypertension, an on-target event known to reflect effective VEGF pathway inhibition and one managed by anti-hypertensive medication. Detailed results of the trial will be submitted for presentation at an upcoming major medical meeting.

Based on results from the TIVO-3 trial, together with the previously completed TIVO-1

trial of tivozanib in the first-line treatment of RCC, the Company plans to submit a potential New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in approximately six months.

Tivozanib TiNivo Study Update

Updated Phase 2 Results from the TiNivo Trial of Tivozanib and Nivolumab (OPDIVO) in RCC Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. Updated Phase 2 data from the Phase 1b/2 TiNivo study of tivozanib in combination with nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, were presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Munich. As of the date of the presentation, the Phase 1b/2 study had enrolled a total of 28 patients, and the Phase 2 portion of the study (n=22) was designed to assess the safety, tolerability, and anti-tumor activity of the full dose and schedule of oral tivozanib as established in the Phase 1b portion of the study.

The data demonstrated that the tivozanib-nivolumab combination continued to exhibit synergistic efficacy and favorable tolerability. Treatment-related Grade 3/4 adverse events occurred in 60% of patients, the most common of which was hypertension. Preliminary efficacy was assessed in all 25 patients, who were treated with the full dose and schedule of oral tivozanib in combination with intravenous nivolumab. Of these patients, 13 (52%) had received at least one prior systemic therapy, including 2 (8%) that had received prior PD-1 therapy, and 12 (48%) were treatment naïve. An overall response rate was observed in 14 patients (56%) (complete response plus partial response), including 1 patient (4%) achieving a complete response, and a disease control rate (complete response plus partial response plus stable disease) was observed in 24 patients (96%). The 2 patients (8%) who received prior PD-1 therapy both achieved a partial response. At the time of data collection, 13 patients (52%) remained on study and 18 patients (72%) had tumor shrinkage of at least 25%, with a majority of patients having disease control for at least 48 weeks.

Tivozanib (FOTIVDA) European Union Updates

Tivozanib (FOTIVDA) Launched in Sweden, the Netherlands and Scotland for the Treatment of RCC. Since the beginning of the third quarter of 2018, FOTIVDA was launched in Sweden, the Netherlands and Scotland for the first-line treatment of adult patients with RCC, following price and reimbursement approvals within each country. FOTIVDA is now available in Germany, the U.K., Austria, the Netherlands and Sweden. FOTIVDA was granted European Commission approval in August 2017 for the treatment of adult patients with RCC in the European Union plus Norway and Iceland.

Under its agreement with EUSA Pharma, licensee for tivozanib in the territories of Europe (excluding Russia, Ukraine and the Commonwealth of Independent States), Latin America (excluding Mexico), Africa and Australasia for all diseases and conditions in humans, excluding non-oncologic diseases or conditions of the eye, AVEO is entitled to double-digit royalty payments on net sales of FOTIVDA in Europe, up to $8.0 million in

milestone payments for potential reimbursement approvals for Germany, France, Italy, and Spain and a potential $20.0 million R&D reimbursement payment for access to TIVO-3 trial data in addition to other regulatory and commercial milestone payments.

Ficlatuzumab Update

Trials in Progress Poster for Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. An investigator-sponsored Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC) was presented as a trials in progress poster at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. This randomized multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.

CAN017 (AV-203) Update

CANbridge IND for CAN017 (AV-203) Trial in Esophageal Squamous Cell Cancer Accepted in China. In August 2018, AVEO announced that the China National Drug Administration (CNDA) accepted CANbridge Life Sciences’ Investigational New Drug (IND) Application for a Phase 1b/3 clinical trial of CAN017 (AV-203), AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate, in esophageal squamous cell cancer (ESCC). Under the terms of a March 2016 agreement, the acceptance of the IND triggered a $2.0 million milestone payment to AVEO from CANbridge Life Sciences. CANbridge licensed worldwide rights, excluding the United States, Canada, and Mexico, to AV-203 from AVEO, and AVEO is eligible to receive up to $40.0 million in potential additional development and regulatory milestone payments and up to $90.0 million in potential commercial milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives.

Financial Update

Secured Additional Funding through Offering of Common Stock. In August 2018, AVEO announced an underwritten public offering of 2,500,000 shares of common stock at a price of $2.26 per share, resulting in aggregate gross proceeds of $5.7 million. In October and November 2018, the Company sold 3,781,389 shares of its common stock in at-the market transactions pursuant to its sales agreement with Leerink Partners LLC (Leerink) and received approximately $8.4 million in net proceeds.

Third Quarter 2018 Financial Highlights

AVEO ended Q3 2018 with $20.4 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.

Total revenue for Q3 2018 was approximately $2.5 million compared with $4.6 million for Q3 2017.

Research and development expense for Q3 2018 was $5.2 million compared with $4.7 million for Q3 2017.

General and administrative expense for Q3 2018 was $2.7 million compared with $2.1 million for Q3 2017.

Net loss for Q3 2018 was $22.2 million, or a loss of $0.18 per basic and diluted share, compared with net loss of $26.4 million for Q3 2017, or a loss of $0.22 per basic and diluted share. Approximately $16.2 million of Q3 2018 net loss was a non-cash loss attributable to the increase in the fair value of the 2016 private placement warrant liability that principally resulted from the increase in the stock price that occurred within the quarter. In Q3 2017, the non-cash loss attributable to the increase in the fair value of such warrant liability was $23.5 million.

Financial Guidance

AVEO believes that its $20.4 million in cash, cash equivalents, and marketable securities at the end of Q3 2018 and the additional $8.4 million raised from sales under its sales agreement with Leerink in October and November 2018 would allow it to fund planned operations into the second quarter of 2019. This estimate assumes no receipt of additional milestones from AVEO’s partners, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of outstanding warrants issued in connection with the 2016 private placement or outstanding warrants issued in connection with the recent settlement of the securities class action litigation.