Month: March 2017

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-Q, Progenics Pharmaceuticals, 2017, MAR 9, 2017, View Source [SID1234518051])

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Ipsen announces data presentations of lanreotide (Somatuline® Autogel®), telotristat ethyl and the investigational compound 177Lu-OPS201 at the European Neuroendocrine Tumor Society (ENETS) 2017 conference

On March 9, 2017 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group, reported that Somatuline Autogel (lanreotide), telotristat ethyl and the investigational compound 177Lu-OPS201 are the subject of 23 presentations at the European Neuroendocrine Tumor Society (ENETS) 2017 conference (Press release, Ipsen, MAR 9, 2017, View Source [SID1234518220]).

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"We are very excited to participate in this meeting and to share data regarding lanreotide, telotristat ethyl and 177Lu-OPS201," said Dr. Sotirios Stergiopoulos, SVP Head of Global Medical Affairs, Ipsen. "In addition, Ipsen supported several projects to understand the biology, epidemiology, treatment patterns and unmet needs of patients living with Neuroendocrine Tumors (NETs). All of this demonstrates IPSEN’s commitment to improving the life of patients living with NETs."

Lanreotide (Somatuline Autogel) is featured in 17 presentations:

ABSTRACTS SELECTED FOR ORAL PRESENTATIONS

[A10] Krug S et al. Interactions between SSTR Modulation via Lanreotide and Molecular Targeted Therapies in Sequential and Combination Approaches in Vitro. Session: ENETS/NANETS Young Investigator Symposium

[K12] Martínez-López A et al. Efficacy of Lanreotide (LAN), both Alone and in Combination with Targeted Therapies in a Preclinical Model of Pancreatic Neuroendocrine Tumors (pNETs). Session: 4A – Basic Science Abstracts

ABSTRACTS SELECTED FOR POSTER SESSION

[K17] Phan AT et al. Safety and Tolerability of Lanreotide Autogel/Depot (LAN) in Patients (pts) with Neuroendocrine Tumours (NETs): Pooled Analysis of Clinical Studies

[K18] Phan AT et al. Long-Term Efficacy and Safety with Lanreotide Autogel/Depot (LAN) from CLARINET and Open-Label Extension (OLE) Studies

[K5] Duchateau L et al. An Exploratory Patient Centric Analysis of the ELECT Trial: A Phase 3 Study of Efficacy and Safety of Lanreotide Autogel/Depot (LAN) Treatment for Patients (pts) with Carcinoid Syndrome (CS)

[C5] Meyer T et al. CALM-NET, A Multicentre, Exploratory Study to Assess the Clinical Value of Circulating Tumour Cells (CTCs) Enumeration in Patients (Pts) with Functioning Midgut NETs Receiving Lanreotide Autogel (LAN)

[K1] Albertelli M et al. Safety and Efficacy of High Doses Lanreotide Treatment in Patients with Progressive Neuroendocrine Tumors: Results from a Prospective Phase II Trial. Note: This is an investigator-sponsored trial.

[K15] Pavel M et al. Safety and Efficacy of 14-Day Dosing Interval of Lanreotide Autogel/Depot (LAN) for Patients with Pancreatic or Midgut Neuroendocrine Tumours (NETs) Progressing on LAN Every 28 Days: The Prospective, Open-label, International, Phase 2 CLARINET FORTE Study

[J8] Lepage C et al. REMINET: A European, Multicenter, Phase II/III Randomized Double-Blind, Placebo-Controlled Study Evaluating Lanreotide As Maintenance Therapy after First-Line Treatment in Patients with Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors. Note: This is an investigator-sponsored trial.

[K2] Almquist M et al. STREET – Somatostatin Treatment Experience Trial

[A12] Lelek S et al. Antiproliferative Effects of Lanreotide in Neuroendocrine Tumors. Note: This is an investigator-sponsored trial.

[K20] Reidy-Lagunes D et al. Lanreotide Autogel/Depot (LAN) in Lung Neuroendocrine Tumours (NETs): The Randomized, Double-Blind, Placebo (PBO)-Controlled, International Phase 3 SPINET Study

[K7] Ferolla P et al. Open-Label Multicentre Single-Arm Phase 2 Trial of Lanreotide Autogel (LAN) in Combination with Temozolomide (TMZ) in Patients with Advanced Well/Moderately Differentiated Neuroendocrine Tumours (NETs) of Lung and Thymus: ATLANT

[K9] Geilvoet W et al. Patient Satisfaction Regarding Home Injection Service for Somatostatin Analogues: A Survey among Patients with a Neuroendocrine Tumour. Note: This is an investigator-sponsored trial.

[N15] Prasad V et al. Lanreotide Autogel/Depot (LAN) in Combination with Peptide Receptor Radionuclide Therapy (PRRT) in Progressive Digestive and Lung Neuroendocrine Tumours (NETs): Design of the PRELUDE Study

[Q36] van Fraeyenhove F et al. Tumor Growth Rate to Assess Tumor Activity in Patients with Lung Neuroendocrine Tumors on Lanreotide Autogel: A Case-Series Analysis. Note: This is an investigator-sponsored trial.

[K19] Prinzi N et al. Safety of Lanreotide 120 mg ATG (LAN) in Combination with Metformin (MET) in Patients (pts) with Progressive Advanced Well-Differentiated (WD) Gastro-Intestinal (GI) or Lung Carcinoids. A Pilot, One-Arm, Open-Label, Prospective Study: The MetNET-2 Trial. Note: This is an investigator-sponsored trial.

Telotristat ethyl is featured in 5 presentations:

ABSTRACTS SELECTED FOR POSTER SESSION

[K16] Pavel M et al. Telotristat Ethyl in Carcinoid Syndrome: Safety and Efficacy Results of an Open-Label Extension of the TELECAST Phase 3 Clinical Trial

[L2] Anthony L et al. Impact of Concomitant Medication on Efficacy of Telotristat Ethyl – A Post Hoc Subgroup Analysis of the Phase 3 TELESTAR Study in Carcinoid Syndrome

[L7] Lapuerta P et al. Integrated Safety Analysis of Telotristat Ethyl in Patients with Carcinoid Heart Disease

[M3] Cella D et al. Relationship Between Symptoms and HRQoL Benefits in Patients (pts) with Carcinoid Syndrome (CS): A Post-Hoc Analysis of Telotristat Ethyl (TE) TELESTAR Trial

[M8] Pavel M et al. Correlation of Plasma (p) and Urine (u) 5-HIAA Levels in Patients (pts) with Carcinoid Syndrome (CS) – Post-Hoc Analyses from the TELESTAR Study

177Lu-OPS201 is featured in one presentation:

ABSTRACT SELECTED FOR POSTER SESSION

[N12] Nicolas G et al. Peptide Receptor Radionuclide Therapy (PRRT) with a Somatostatin Receptor (SSTR) Antagonist in Patients with SSTR-Positive, Progressive Neuroendocrine Tumours (NETs): A Phase I/II Open-Label Trial to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201

OncoResponse Announces Final Closing of $22.5M Series A Financing Round

On March 9, 2017 OncoResponse, an immuno-oncology antibody discovery company, reported that it has closed its ongoing $22.5 million Series A financing round and has appointed Mike Gallatin, Ph.D., Albert Yu, M.D., and Elizabeth Jaffee, M.D. to its Scientific Advisory Board (SAB) (Press release, OncoResponse, MAR 9, 2017, View Source [SID1234522897]). The newly-appointed SAB members join original members James Welsh, M.D. and David Hong, M.D., both investigators at MD Anderson Cancer Center. Kristine Swiderek, Ph.D., CSO of OncoResponse, is chair of the SAB.

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In October 2015, OncoResponse secured an initial closing of its Series A financing co-led by ARCH Venture Partners, Canaan Partners, and MD Anderson, with William Marsh Rice University and Alexandria Real Estate Equities also participating. In May 2016, OncoResponse secured an additional investment by Baxalta (now Shire), which was followed by supplemental investments from GreatPoint Ventures and the Helsinn Investment Fund in October 2016. The recent investment by current insiders and HT Family Office brings the total Series A financing to $22.5 million, which will be used to support OncoResponse’s ongoing efforts to interrogate the humoral response of elite responders to cancer immunotherapy to identify antibodies and potential targets for novel therapeutic development.

OncoResponse utilizes a clinically validated platform technology to rapidly screen antibodies made by the human immune system and identify those with exceptional reactivity to cancer. The Company has a strategic alliance with MD Anderson Cancer Center, which provides continuous access to patient samples across multiple cancer indications and to oncology and translational medicine expertise including clinical and regulatory input.

"HT Family Office is an excellent addition to our solid investor base and we warmly welcome them along with our new Scientific Advisory Board members, who bring extensive industry and oncology expertise to our team," said Clifford J. Stocks, CEO of OncoResponse. "With the final closing of our Series A, we look ahead to the continued development of our research programs that aim to expand the promise of immuno-oncology by identifying therapeutically relevant antibodies from patients with elite response to cancer immunotherapy in a number of oncology indications."

"OncoResponse’s approach to addressing the unmet need in patients who are partial or non-responders to immunotherapy is harmonized with our investment strategy," said Alvin Syh, General Manager of HT Family Office. "We are honored to be able to support the advancement of this potentially transformative technology at such a crucial time in the Company’s development."

New members of the OncoResponse Scientific Advisory Board include:

Mike Gallatin, Ph.D.

Dr. Gallatin is a Senior Advisor on the Frazier Healthcare Partners Life Sciences team and brings over 35 years of experience as a scientist and executive to the OncoResponse Scientific Advisory Board. He co-founded Calistoga Pharmaceuticals (acquired by Gilead) and Stromedix Pharmaceuticals (acquired by Biogen Idec) and served as President of Calistoga, which was the first company to demonstrate the clinical benefit of an isoform selective PI3K (idelalisib) inhibitor in hematologic malignancies. Dr. Gallatin was one of the founding scientists at ICOS Corporation (acquired by Eli Lilly and Company), where he served as VP and Scientific Director. Earlier in his career, Mike developed expertise in the fields of immunology/inflammation and oncology while on the faculty at the Fred Hutchinson Cancer Center. Dr. Gallatin received his Ph.D. from the University of Alberta Department of Immunology and was a Damon Runyon-Walter Winchell and American Cancer Society fellow at Stanford University in the laboratory of Dr. Irving Weissman.

Albert Yu, M.D.

Dr. Yu has over 20 years of clinical drug development experience and expertise. He previously served as Vice President of Clinical Development at Omeros Corporation and as Chief Medical Officer and Vice President of Clinical Affairs at Calistoga Pharmaceuticals. At Calistoga, he played a key role in the development of Zydelig for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. Prior to that, he was Senior Director of Clinical Operations, Research & Affairs at ICOS Corporation, where he was instrumental in the development of Cialis for the treatment of erectile dysfunction. Dr. Yu received his B.S. in biology from Massachusetts Institute of Technology and his M.D. from the University of Washington. He is trained in internal medicine, critical care medicine and pulmonary disease.

Elizabeth M. Jaffee, M.D.

Dr. Jaffee is an international leader in the development of immune based therapies for pancreatic and breast cancers. She is currently Deputy Director of the Sidney Kimmel Comprehensive Cancer Center and Professor of Oncology at Johns Hopkins University, where her research focuses on evaluating mechanisms of immune tolerance to cancer, the identification of human tumor antigens recognized by T cells, and the analysis of antitumor immune responses in breast and pancreatic cancers. Prior to joining Johns Hopkins, she served as a research fellow and principal investigator at the University of Pittsburgh. Dr. Jaffee received her B.A. in biology and immunology magna cum laude from Brandeis University and her M.D. from New York Medical College. She completed her medical residency at Presbyterian-University Hospital in Pittsburgh, Pennsylvania.

BeiGene Announces Initiation of Pivotal Study in China with BTK Inhibitor BGB-3111 in Patients with Relapsed or Refractory CLL/SLL

On March 9, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the dosing of the first patient in a pivotal clinical trial of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, in Chinese patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, BeiGene, MAR 9, 2017, View Source [SID1234518060]). BGB-3111 is also currently being evaluated in a pivotal Phase II clinical trial in Chinese patients with relapsed or refractory mantle cell lymphoma (MCL) and a global Phase III clinical trial in comparison with ibrutinib for the treatment of patients with Waldenström’s Macroglobulinemia.

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"We are pleased to announce the start of the second pivotal clinical trial of BGB-3111 in China. With this trial, we hope to demonstrate BGB-3111’s efficacy and safety in Chinese patients with CLL/SLL and build upon the promising data we presented at last year’s ASH (Free ASH Whitepaper) annual meeting from the global Phase I trial of BGB-3111 in patients with CLL/SLL," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

"We hope that our pivotal program for BGB-3111 in China, with trials currently underway in MCL and CLL/SLL, will allow us to broadly and rapidly develop BGB-3111 for the benefit of cancer patients in China," commented Lai Wang, Ph.D., Head of China Development.

The Phase II single-arm, open-label, multi-center study is designed to investigate the efficacy and safety of BGB-3111 in patients with relapsed or refractory CLL/SLL. The trial’s primary endpoint is the objective response rate, defined as achievement of either a partial response or complete response at any time on study drug. Secondary endpoints include progression free survival, duration of response, time to response, safety, and tolerability. Professor Jianyong Li of the Jiangsu Province Hospital, the first Affiliated Hospital with Nanjing Medical University, is the lead principal investigator of the trial.

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib (the only BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency) based on biochemical assays, higher exposure than ibrutinib based on their respective Phase I experience, and sustained 24-hour BTK occupancy in both the blood and the lymph node.

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2016 Financial Results and Recent Highlights

On March 9, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Sunesis, MAR 9, 2017, View Source [SID1234518055]). Loss from operations for the three months and year ended December 31, 2016 was $8.1 million and $36.5 million, respectively. As of December 31, 2016, cash, cash equivalents and marketable securities totaled $42.6 million.

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"We are making meaningful progress in advancing our two lead programs, vosaroxin and SNS-062, in areas of unmet need in hematologic malignancies," said Daniel Swisher, Chief Executive Officer of Sunesis. "Our European Marketing Authorization Application is on track; we are working diligently to submit responses this quarter to the Day 180 List of Outstanding Issues and we are preparing to go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, culminating in a likely CHMP decision by mid-year. We continue, in parallel, to advance active dialogues with potential pharma collaborators toward the goal of supporting a potential market launch of vosaroxin in Europe in the second half of this year."

Mr. Swisher continued, "Our BTK inhibitor program is advancing as planned. The IND for SNS-062 is now active and we expect to initiate a Phase 1B/2 study in patients with advanced B-cell malignancies in the second quarter. We were encouraged by the data from the Phase 1A Healthy Volunteer study and the level of interest generated at our ASH (Free ASH Whitepaper) 2016 presentation."

Fourth Quarter 2016 and Recent Highlights

Continued Progress with the Marketing Authorization Application (MAA) for Vosaroxin in Europe. In January, Sunesis announced that it had received the Day 180 List of Outstanding Issues from the European Medicines Agency (EMA), issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process. The Company plans to submit its response to the list by the end of the first quarter. In addition, the Company announced that it will go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, which will assist the CHMP in its evaluation of the MAA. Sunesis anticipates an approval decision on vosaroxin by mid-year.

Announced Active IND for SNS-062 and Trial Initiation Plans in Phase 1B/2 Study in Patients with Advanced B-Cell Malignancies. In January, Sunesis announced that its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) was active, supporting the initiation of a Phase 1B/2 study to assess the candidate’s safety and efficacy in patients with advanced B-cell malignancies after prior ibrutinib exposure, including in patients with C481S mutations. Phase 1A of the study examined the safety, pharmacodynamics, and pharmacokinetics of SNS-062 and was completed during the fourth quarter of 2016, and the Company plans to begin dosing patients in the Phase 1B/2 study within the first half of 2017.

Announced Poster Presentation on BTK Inhibitor SNS-062 at the AACR (Free AACR Whitepaper) Annual Meeting. Today, Sunesis announced a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting to be held April 1-5 in Washington, D.C. The poster, titled "SNS-062 demonstrates efficacy in chronic lymphocytic leukemia in vitro and inhibits C481S mutated Bruton tyrosine kinase" (Poster Number 22, Abstract Number 1207, Convention Center, Halls A-C, Poster Section 6), details results from an Ohio State University-sponsored preclinical study, conducted in collaboration with Sunesis, that examines the potency of SNS-062 versus ibrutinib and acalabrutinib, specifically relating to the C481S mutation. The results will be presented in a session titled "Reversal of Drug Resistance" on Monday, April 3, 2017 from 8:00 AM to 12:00 PM Eastern Time.

Presentation of Updated Results from the VALOR Trial Evaluating Vosaroxin in AML and Completed Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK Inhibitor SNS-062 at ASH (Free ASH Whitepaper) Annual Meeting. In December 2016, Sunesis presented updated results from the VALOR Trial examining overall survival in patients age 60 years and older with relapsed/refractory acute myeloid leukemia (AML), as well results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent reversible BTK inhibitor SNS-062 at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California. The oral presentation, titled "Durable Overall Survival Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated Results from the Valor Trial" and the poster titled "First-in-Human Phase 1a Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton’s Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects," are available on the Sunesis website at www.sunesis.com.

Completion of $25.9 million Financing. In October, Sunesis announced the completion of an equity financing with net proceeds of $25.9 million. The financing attracted participation from leading biotechnology investors.

Announced Organizational Updates. Today, Sunesis announced two management additions, Judy Fox Ph.D., to the position of Chief Scientific Officer and Pietro Taverna, Ph.D. to Executive Director, Translational Medicine. Dr. Fox brings over 25 years of experience both as a scientist and program leader at leading life science companies. At Sunesis, she and her team will develop and implement strategic research roadmaps to support the advancement of Sunesis’ product portfolio. She obtained her Ph.D. in Biological Chemistry from M.I.T. Pietro Taverna, Ph.D. returns to Sunesis from Astex/Otsuka Pharmaceuticals, where he led the Translational Pharmacology department and was responsible for biomarker strategy and the translation of research insights into optimal clinical development. He holds a Ph.D. from M. Negri Institute for Pharmacological Research in Milan. Additionally, Jennifer Troia was promoted to Vice President, Human Resources. Jennifer brings over 25 years of related HR experience, including at Gilead Sciences, COR Therapeutics, CoMentis and Sunesis.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $42.6 million as of December 31, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $3.8 million was primarily due to $37 million of net cash used in operating activities and $7.2 million of final payments against notes payable and $0.8 million of principal payments against notes payable, partially offset by net proceeds of $25.9 million from the underwritten offering and $14.8 million in net loan proceeds, and $0.3 million from the sale of our common stock through the Sales Agreement with Cantor and exercise of stock options.

Revenues for the three months and year ended December 31, 2016 were $0.7 million and $2.5 million, as compared to $0.7 million and $3.1 million for the same periods in 2015. The decrease between the periods was primarily due to the extension of the amortization period of our deferred revenue.

Research and development expenses were $4.8 million and $22.9 million for the three months and year ended December 31, 2016, as compared to $7.6 million and $23.7 million for the same periods in 2015. The decrease of $0.8 million in 2016 was primarily due to a decrease of $2.2 million in personnel costs partially offset by increases in professional services, clinical trials and medical affairs expenses.

General and administrative expenses for the three months and year ended December 31, 2016 were $3.9 million and $16 million, as compared to $4.4 million and $18.7 million for the same periods in 2015. The decrease of $2.6 million in 2016 was primarily due to decrease in professional services and personnel costs.

Interest expense was $0.5 million and $1.7 million for the three months and year ended December 31, 2016, as compared to $0.2 million and $0.9 million for the same periods in 2015. The increases in the 2016 periods were primarily due to the increase in the notes payable.

Net other income was $0.2 million in 2016 as compared to $3.6 million in 2015. The 2015 amount was primarily comprised of net non-cash credit for the revaluation of warrants issued in the 2010 Offering.

Cash used in operating activities was $37.0 million for the year ended December 31, 2016, as compared to $38.7 for the same period in 2015. Net cash used in operating activities in 2016 resulted primarily from the net loss of $38.0 million and net adjustment for the non-cash items of $5.2 million offset by changes in operating assets and liabilities of $4.1 million (including $2.4 million related to recognition of deferred revenue under the Royalty Agreement).

Sunesis reported loss from operations of $8.1 million and $36.5 million for the three months and year ended December 31, 2016, as compared to $11.3 million and $39.3 million for the same periods in 2015. Net loss was $8.5 million and $38.0 million for the three months and year ended December 31, 2016, as compared to $11.6 million and $36.7 million for the same periods in 2015.