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Sunesis Pharmaceuticals Reports Second Quarter 2015 Financial Results and Recent Highlights

On July 30, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the second quarter ended June 30, 2015. Loss from operations for the three and six months ended June 30, 2015 was $10.6 million and $19.4 million, respectively (Press release, Sunesis, JUL 30, 2015, View Source;p=RssLanding&cat=news&id=2072752 [SID:1234506755]). As of June 30, 2015, cash, cash equivalents and marketable securities totaled $39.6 million.

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"We remain committed to moving vosaroxin forward as an important new therapy for patients with AML, and to realizing the value of this product candidate for all our constituents," said Daniel Swisher, Chief Executive Officer of Sunesis. "As part of this effort, we are moving forward rapidly toward the filing of a marketing authorization application in Europe and are carefully evaluating and refining our plans to gain marketing approval in the U.S. As we continue to advance these strategies and work toward key milestones with our kinase inhibitor pipeline, we are also evaluating and prioritizing our spending to ensure our ability to realize the value of our portfolio."

Second Quarter 2015 Highlights

Received European regulatory guidance regarding potential marketing authorization application for Vosaroxin in AML. In July 2015, Sunesis announced that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for vosaroxin in Europe, the company is proceeding with an MAA filing. The MAA will focus on the indication of relapsed/refractory acute myeloid leukemia (AML) in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the company’s pivotal Phase 3 study of vosaroxin in adult patients with relapsed or refractory AML.

Received feedback from FDA regarding NDA filing for Vosaroxin in AML. In July 2015, Sunesis announced that, following a recent meeting with the U.S. Food and Drug Administration (FDA), the FDA recommended that the company provide additional clinical evidence to support a future NDA submission. The company is currently evaluating and refining its plan to gain marketing approval in the U.S. based on this feedback.

Announced presentation of new data at EHA (Free EHA Whitepaper) 2015 from predefined subgroup of patients age 60 years and older enrolled in VALOR. In June 2015, Sunesis announced the presentation of results from predefined subgroups of patients age 60 years and older enrolled in VALOR. The results were presented at the 20th Congress of the European Society of Hematology in Vienna, Austria. The poster, titled "Improved survival in patients ≥60 with first relapsed/refractory acute myeloid leukemia treated with vosaroxin plus cytarabine vs placebo plus cytarabine: results from the Phase 3 VALOR study," as well as an additional poster presented at the meeting, titled "Allogeneic transplant in patients ≥60 years of age with first relapsed or refractory acute myeloid leukemia after treatment with vosaroxin or placebo plus cytarabine: results from VALOR," are available on the Sunesis website as www.sunesis.com.

Announced presentation of VALOR trial subgroup analysis at ASCO (Free ASCO Whitepaper) 2015. In May 2015, Sunesis announced the presentation of results from a post hoc subgroup analysis of patients age 60 years and older who underwent allogeneic hematopoietic cell transplant (HCT) in the VALOR trial. The poster, titled "Allogeneic hematopoietic cell transplant (HCT) in patients (pts) ≥ 60 years of age with first relapsed or refractory acute myeloid leukemia (R/R AML) after treatment with vosaroxin plus cytarabine (pla/cyt): results from VALOR", is available on the Sunesis website at www.sunesis.com.

Financial Highlights

Cash, cash equivalents and marketable securities totaled $39.6 million as of June 30, 2015, as compared to $43.0 million as of December 31, 2014. The decrease of $3.4 million was primarily due to $19.8 million of net cash used in operating activities and $1.6 million of principal payments against notes payable, partially offset by $18.0 million raised from the sale of common stock through the company’s at-the-market facility with Cantor Fitzgerald & Co. and from option exercises. A further $0.4 million was raised in July through this facility, resulting in a pro-forma June 30, 2015 cash balance of $40.0 million. This capital is expected to be sufficient to fund the company to the middle of 2016.

Revenue for the three and six months ended June 30, 2015 was $0.9 million and $1.7 million as compared to $2.0 million and $4.0 million for the same periods in 2014. Revenue in each period was primarily due to deferred revenue recognized related to the royalty agreement with Royalty Pharma.

Research and development expense was $6.3 million and $10.8 million for the three and six months ended June 30, 2015 as compared to $7.2 million and $14.8 million for the same periods in 2014. The decreases between the comparable three and six month periods were primarily due to reductions in clinical trial expenses in each case.

General and administrative expense was $5.2 million and $10.3 million for the three and six months ended June 30, 2015 as compared to $6.4 million and $9.8 million for the same periods in 2014. The decrease between the comparable three month periods was primarily due to decreases in personnel costs and outside services costs. The increase between the comparable six month periods was primarily due to an increase in outside services costs.

Interest expense was $0.2 million and $0.5 million for the three and six months ended June 30, 2015 as compared to $0.5 million and $1.0 million for the same periods in 2014. The decreases in the 2015 periods were due to the reduced principal balance outstanding on notes payable.

Net other income was $1.9 million and $1.8 million for the three and six months ended June 30, 2015 as compared to $0.3 million of net other income and $4.8 million of net other expense for the same periods in 2014. The amounts for each period were primarily comprised of non-cash credits or charges for the revaluation of warrants issued in 2010.

Cash used in operations was $19.8 million for the six months ended June 30, 2015 as compared to $21.6 million for the same period in 2014. Net cash used in the 2015 period resulted primarily from the net loss of $18.1 million and changes in operating assets and liabilities of $3.4 million, partially offset by net adjustments for non-cash items of $1.7 million.

Sunesis reported loss from operations of $10.6 million and $19.4 million for the three and six months ended June 30, 2015 as compared to $11.6 million and $20.6 million for the same periods in 2014. Net loss was $8.9 million and $18.1 million for the three and six months ended June 30, 2015 as compared to $11.8 million and $26.4 million for the same periods in 2014.
About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

Juno Announces FDA Clearance of Investigational New Drug Application for JCAR015 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

On July 30, 2015 Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) (Press release, Juno, JUL 30, 2015, View Source [SID:1234506765]).

The IND enables Juno to initiate a multi-center, pivotal Phase 2 trial evaluating JCAR015 in patients with r/r ALL. The trial is scheduled to begin in the near term, with the potential to file for registration by late 2016 or early 2017. JCAR015, Juno’s most advanced product candidate, is an autologous chimeric antigen receptor (CAR) T cell immunotherapy targeting CD19, a protein expressed on the surface of most B cell leukemias and lymphomas.

"Based on the encouraging results of JCAR015 in its Phase 1 adult ALL trial conducted by Memorial Sloan Kettering Cancer Center, we are excited to begin Juno’s first pivotal trial investigating this product candidate in a multi-center study," said Mark Frohlich, M.D., Juno EVP of development and portfolio strategy. "FDA clearance of the JCAR015 IND for this pivotal Phase 2 trial is a significant milestone for the company, highlighting the early returns on the investments we have made in process development and manufacturing as well as providing clarity on a potential path toward our first product approval."

The initial trial to be conducted under this IND is titled "Protocol 015001: A Phase 2, single-arm, Multicenter Trial to Determine the Efficacy and Safety of JCAR015 in Adult Subjects with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia (The ROCKET Study)." The primary objective of this trial is to evaluate the efficacy of JCAR015 as measured by overall remission rate in subjects with morphologic evidence of disease (5% or more leukemic blasts in the bone marrow). The trial will also evaluate the safety and tolerability of the therapy. The study will open at 14 clinical sites in the U.S. and enroll approximately 90 subjects in order to achieve 50 subjects with morphologic disease following salvage chemotherapy.

About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s chimeric antigen receptor (CAR) and T cell receptor technologies (TCR) genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cells surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.

Ligand Enters into Commercial License and Supply Agreement with Sanofi for Captisol-enabled SAR-125844

On July 30, 2015 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported it has entered into a global license and supply agreement with Sanofi to utilize Captisol in the development and commercialization of SAR-125844, a potent MET kinase inhibitor (Press release, Ligand, JUL 30, 2015, View Source [SID:1234506760]).

Under the terms of the license, Ligand will be eligible to receive potential milestone payments, royalties on future net sales and revenue from Captisol material sales. Sanofi will be responsible for all costs related to the program.

"This represents the progression and expansion of our relationship with Sanofi as they continue to make progress on SAR-125844, a novel, selective MET kinase inhibitor," commented John Higgins, President and Chief Executive Officer of Ligand. "Captisol continues to bring significant value to our partners’ programs and shows great promise in enabling compounds in oncology, CNS, anti-infectives and many other therapy areas."

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled seven FDA-approved products, including Amgen’s Kyprolis, Baxter International’s Nexterone and Merck’s NOXAFIL IV. There are more than 30 Captisol-enabled products currently in clinical development.

About SAR-125844

SAR-125844 is a potent, selective and reversible ATP-competitive MET tyrosine kinase inhibitor for intravenous (IV) administration. SAR-125844 recently completed a first-in-human, open-label, non-randomized, single agent, Phase 1 study in advanced/refractory solid tumor patients.

Tesaro and Jiangsu Hengrui Medicine Announce Rolapitant License Agreement for China

On July 30, 2015 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Jiangsu Hengrui Medicine Co., Ltd., a fully integrated pharmaceutical company based in China, reported an exclusive license agreement for the development, registration, manufacture, and commercialization of rolapitant in China (Press release, TESARO, JUL 30, 2015, View Source [SID:1234506756]).

Hengrui will make upfront and milestone payments to TESARO subject to the achievement of certain events, in addition to royalty payments on annual net sales in China. Additional financial details were not disclosed.

"TESARO is committed to advancing new therapeutic options for patients with cancer, and we are pleased to be working with Hengrui to develop and commercialize rolapitant for patients in China," said Lonnie Moulder, CEO of TESARO. "Hengrui is a leading innovative pharmaceutical company in China, with a substantial portfolio of marketed oncology products, deep regulatory expertise, and a robust pipeline of product candidates. With a strong commitment to quality and a significant level of expertise in clinical development, regulatory affairs, and commercialization, we believe Hengrui is the optimal partner to develop rolapitant in China."

Piaoyang Sun, Chairman of the Board of Hengrui, added, "As one of the leading pharmaceutical companies in China, Hengrui has a rich history of delivering high quality oncology products worldwide and continues to be committed to developing innovative oncology medicines. In recent years, Hengrui has expanded its oncology portfolio to include cancer supportive care products, and the development and commercialization of rolapitant for China is the most recent example of our effort to make new therapeutic options available to millions of cancer patients here. We are extremely pleased to be working with TESARO, an emerging leader in the development of oncology specialty medicines."

Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). The New Drug Application (NDA) for oral rolapitant is currently under review by the U.S. Food and Drug Administration, with a PDUFA goal date of September 5, 2015. Rolapitant has not been approved by any regulatory agency.

Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy

On July 30, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported it has submitted the cobas EGFR Mutation Test v2 for Premarket Approval (PMA) to the U.S. Food and Drug Administration (FDA), as a companion diagnostic test for AZD9291, an AstraZeneca investigational therapy for non-small cell lung cancer patients with an acquired resistant mutation (Press release, Hoffmann-La Roche , JUL 30, 2015, View Source [SID:1234506754]).

Patients with non-small cell lung cancer who have adenocarcinoma with tumor containing an EGFR sensitizing mutation show significant benefit from currently available EGFR TKI therapies. However, approximately two-thirds of these patients will relapse and develop drug resistance. In many cases, this resistance is caused by an acquired mutation called T790M. The cobas EGFR v2 test can aid clinicians to appropriately select NSCLC patients who have acquired the T790M mutation and are most likely to benefit from AstraZeneca’s novel therapy.

"The collaboration with AstraZeneca to be the companion diagnostic for their third generation EGFR drug therapy is a testament to the innovation and quality of Roche oncology assays and demonstrates the value of molecular testing in patients," said Paul Brown, Head of Roche Molecular Diagnostics (RMD). "At Roche Molecular Diagnostics, we have one of the broadest portfolios of FDA-approved tests for Oncology that enable clinicians to make informed treatment decisions for their patients."

"At AstraZeneca, we are focused on developing novel treatments that address the genetic drivers underlying lung cancer disease progression and resistance mechanisms. AZD9291 was designed to inhibit both the activating sensitising EGFRm and the resistance mutation, T790M. The partnership with Roche on developing a companion diagnostics test for AZD9291, ensures that physicians will be able to identify the patients most likely to benefit from the treatment," said Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca.

About the cobas EGFR Mutation Test v2
The cobas EGFR Mutation Test v2 is built upon the existing FDA-approved cobas EGFR Mutation Test, developed by Roche. It is intended to identify a broad spectrum of EGFR mutations for patients with non-small cell lung cancer, including the T790M acquired resistant mutation.

About AZD9291
AZD9291 is a once daily, selective, irreversible EGFR TKI designed to target both the activating sensitising mutation, EGFRm, and T790M, the genetic mutation responsible for EGFR TKI treatment resistance in up to approximately two-thirds of cases of EGFRm advanced NSCLC. AZD9291 has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US Food and Drug Administration (FDA).