On November 5, 2015 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported financial results for the third quarter ended September 30, 2015 (Filing, 8-K, BioCryst Pharmaceuticals, NOV 5, 2015, View Source [SID:1234508001]).

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"The completion of enrollment of our OPuS-2 trial of avoralstat and the successful outcome of the Phase 1 healthy volunteer study of BCX7353 have positioned both programs to reach important value creating events in 2016. We expect to initiate the APeX-1 (Angioedema ProphylaXis) proof of concept trial of BCX7353 in HAE patients and to report OPuS-2 results by early 2016," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "These oral kallikrein inhibitors have the potential to revolutionize HAE treatment, providing patients the ability to lead normal lives."

Third Quarter Financial Results

For the three months ended September 30, 2015, revenues increased to $11.0 million from $3.2 million in the third quarter of 2014. The increase was the result of higher levels of product and collaboration revenue associated with the sale of RAPIVAB (peramivir injection) and the Seqirus, formerly bioCSL, out-licensing transaction, as well as increased collaboration revenue associated with BCX4430 development as a medical counter measure for Ebola virus and other filovirus diseases.

Research and development (R&D) expenses for the quarter increased to $20.1 million from $13.0 million in the third quarter of 2014. The increase in 2015 R&D expenses was primarily due to the advancement of the Company’s hereditary angioedema (HAE) programs, and to a lesser extent, higher expenses associated with two discovery-stage rare disease projects.

Selling, general and administrative (SG&A) expenses for the third quarter 2015 increased to $2.7 million from $1.8 million in 2014. This increase was due primarily to the initiation of activities in preparation for commercialization of the Company’s HAE product candidates, and to a lesser extent, commercial expenses associated with RAPIVAB.

In the third quarter of both 2015 and 2014, interest expense was $1.2 million and related to non-recourse notes payable. In addition, a mark-to-market loss on our foreign currency hedge of $460,000 was recognized in the third quarter of 2015, compared to a gain of $4.1 million in the third quarter of 2014. These gains and losses resulted from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement. During the third quarter of 2015, we also realized a currency hedge gain of $108,000 from the exercise of a U.S. Dollar/Japanese yen currency option.

The net loss for the third quarter of 2015 was $14.6 million, or $0.20 per share, as compared to a net loss of $8.7 million, or $0.12 per share, for the third quarter of 2014.

Cash, cash equivalents and investments totaled $119.7 million at September 30, 2015, compared to $114.0 million at December 31, 2014. Net operating cash use for the third quarter of 2015 was $12.3 million, as compared to $8.0 million in the third quarter of 2014. Net operating cash use for the first nine months of 2015 was $28.1 million, as compared to $19.8 million for the 2014 period.

Year to Date Financial Results

For the nine months ended September 30, 2015, total revenues increased to $43.7 million from $8.2 million in the same period of 2014. The increase in 2015 was primarily due to revenue recognition of $21.7 million associated with the upfront payment from the Seqirus out-licensing transaction, RAPIVAB product revenue, and increased collaboration revenue associated with BCX4430 development.

R&D expenses increased to $53.7 million for the first nine months of 2015 from $33.3 million in the same period of 2014. The increase in 2015 expenses was primarily due to increased spending associated with the Company’s HAE development programs, and to a lesser extent, higher BCX4430 development costs and discovery activity on two rare disease projects.

SG&A expenses increased to $10.3 million for the nine months ended September 30, 2015 from $5.4 million for the nine months ended September 30, 2014. The increase was primarily associated with the initiation of a commercial organization in preparation for commercialization of the Company’s HAE drug candidates, unrestricted grants awarded to the U.S. and international HAE patient advocacy groups, as well as deal-related expenses associated with the Seqirus out-licensing transaction.

In the first nine months of 2015 and 2014, interest expense was $3.9 million and $3.7 million, respectively, and related to the non-recourse notes payable. In addition, a mark-to-market loss on our foreign currency hedge of $793,000 was recognized in the first nine months of 2015, compared to a gain of $732,000 in the same period of 2014. These gains and losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement. We also realized a currency hedge gain of $1.7 million from the exercise of a U.S. Dollar/Japanese yen currency option.

The net loss for the nine months ended September 30, 2015 decreased to $24.9 million, or $0.34 per share, compared to a net loss of $33.5 million, or $0.52 per share, for the same period in 2014.

Clinical Development Update & Outlook

BioCryst recently announced that the OPuS-2 (Oral ProphylaxiS-2) clinical trial of avoralstat completed enrollment of approximately 100 HAE patients, and the Company expects to report results in early Q1 2016.

BioCryst also announced that the randomized, placebo-controlled, Phase 1 clinical trial of orally-administered BCX7353 in healthy volunteers successfully met all of its objectives. Oral BCX7353 was generally safe and well tolerated at all doses up to 500 mg once-daily for 7 days and 350 mg once-daily for 14 days in healthy volunteers, and no dose-limiting toxicity was identified. There were no serious adverse events (AEs) and most AEs were mild. The safety, tolerability, drug exposure and on-target plasma kallikrein inhibition results strongly support advancing the development program into the (APeX-1) Phase 2 proof of concept clinical trial of BCX7353 in HAE patients.

The APeX-1 (Angioedema ProphylaXis) Phase 2, four week dose ranging trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BCX7353 as a preventative treatment to reduce or eliminate attacks in HAE patients is expected to begin by early 2016, with results expected mid-2016.

On October 27, The Japanese Ministry of Health Labor & Welfare (MHLW) announced that BioCryst’s BCX7353 was one of six products designated under MLHW’s new "Sakigake" fast track review system. The Sakigake Designation System promotes R&D in Japan, aiming at early market availability for innovative pharmaceutical products. This designation provides for additional interactions with the regulatory agency in Japan (PMDA) from early development through filing, prioritized development and review, and introduction of the product as soon as possible to address a serious unmet medical need.

Financial Outlook for 2015

Based upon current trends, assumptions, and development plans, BioCryst expects its 2015 net operating cash use to be in the range of $8 to $18 million, upon adjusting the Company’s previously predicted range for the first nine months of operations and including the favorable impact of the Seqirus transaction. In addition, BioCryst continues to expect its operating expenses to be within the range of $75 to $95 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in accurately projecting this expense, as it is significantly impacted by the volatility and price of the Company’s stock, as well as vesting of the Company’s outstanding performance-based stock options.

On November 5, 2015 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage company developing targeted agents and molecular diagnostics to treat the underlying mechanisms of cancer, reported that preclinical data for its lead investigational anticancer therapeutic APTO-253 will be presented at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 5-8, 2015, in Orlando, FL (Filing, 6-K, Aptose Biosciences, NOV 5, 2015, View Source [SID:1234508000]).

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Researchers from the Knight Cancer Institute at Oregon Health & Science University (OHSU) will present data demonstrating the ability of APTO-253 to kill acute myeloid leukemia (AML) cells in the majority of patient samples, with a trend toward correlation with baseline KLF4 expression level. Moreover, APTO-253 demonstrated enhanced killing ability of AML cells in patient samples when combined with either the BET inhibitor JQ1 or with the FLT3 inhibitor quizartinib. The studies were led by OHSU Knight Cancer Institute researcher Jeffrey Tyner, Ph.D., an assistant professor in the Department of Cell, Developmental & Cancer Biology in the OHSU School of Medicine. Beat AML is a collaborative research initiative spearheaded by the OHSU Knight Cancer Institute and The Leukemia & Lymphoma Society.

"These findings further support the ability of APTO-253, a first-in-class KLF4 inducer, to serve as a targeted treatment for AML," commented William G. Rice, Ph.D., Chairman and Chief Executive Officer of Aptose. "Indeed, this emboldens our clinical efforts to develop APTO-253 for use as a single agent and in combination therapies to treat AML and other hematologic malignancies and achieve favorable outcomes with lesser side effects."

The abstract is also available in the online edition of Blood, the official Journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) and on the ASH (Free ASH Whitepaper) conference website:

Abstract Details

Title: "Broad Activity of Apto-253 in AML and Other Hematologic Malignancies Correlates with KLF4 Expression Level"
Date/Time: Saturday, December 5, 2015, 5:30-7:30 p.m.
Location: Orange County Convention Center, Hall A
Abstract #: 83676
Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Additional Abstract

An additional abstract describingthe favorable pharmacokinetics and safety profile of APTO-253 was accepted for publication in the ASH (Free ASH Whitepaper) online conference materials, in the December 3 edition of Blood and in the ASH (Free ASH Whitepaper) and Blood abstract archive.

Title: "Clinical Pharmacokinetics of APTO-253 Support its Use as a Novel Agent for the Treatment of Relapsed or Refractory Hematologic Malignancies"
Abstract #: 4934
Location: Publication

About APTO-253

APTO-253 is a clinical-stage small molecule targeted agent that acts through induction of the innate tumor suppressor gene Krüppel-like factor 4 (KLF4). Suppression of KLF4 gene expression has been reported as a key driver in the leukemogenesis of AML and subsets of other hematologic diseases. Aptose researchers have reported the ability of APTO-253 to upregulate KLF4 expression and induce cell death, or apoptosis, in multiple blood cancer cell lines including AML, as well as in vitro synergy with various classes of conventional approved therapies for AML or myelodysplastic syndromes (MDS).

At last year’s ASH (Free ASH Whitepaper) meeting, Aptose presented data that demonstrated APTO-253’s robust safety profile and potent activity as a single agent and administered in combination with the chemotherapeutic drug azacitadine. In a prior single-agent, Phase 1 clinical study, APTO-253 demonstrated antitumor activity and a robust safety profile in patients with solid tumors.

APTO-253 is currently being evaluated in an ongoing open-label, single-agent, dose-escalating Phase 1b clinical trial in patients with relapsed or refractory hematologic malignancies, including AML and high-risk MDS.

On November 05, 2015 TG Therapeutics, Inc. (Nasdaq:TGTX) reported that updated data for TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202, the Company’s next generation PI3K delta inhibitor, has been selected for presentation at the upcoming 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper), to be held December 5-8, 2015, at the Orange County Convention Center in Orlando, Florida (Press release, TG Therapeutics, NOV 5, 2015, View Source [SID:1234507999]).

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Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated "We are very excited to be able to provide updates on our key Phase 1 and 2 clinical studies for TG-1101 and TGR-1202 at the upcoming ASH (Free ASH Whitepaper) conference. With patients now on once-daily TGR-1202 for durations of over 2.5 years, we and our investigators continue to believe that TGR-1202 has a differentiated safety profile in comparison to other PI3K delta inhibitors and continues to pair nicely with TG-1101 in our proprietary "TG-1303" regimen, which we believe exhibits best-in-class attributes that not only supports our recently announced Phase 3 UNITY-CLL study, but provides a safe and highly active backbone for building novel triple and potentially quad therapies. We are also excited to report data from the first triple therapy of TGR-1202 plus chemotherapy plus a glycoengineered anti-CD20 monoclonal antibody (obinutuzumab) which appeared to be well tolerated with a high level of activity in both front-line CLL patients and patients refractory to BTK inhibitors. We believe these data further support our UNITY-CLL study and also provide a nice comparison to TG-1303, especially from a safety standpoint. Finally, there will be one pre-clinical oral presentation that elucidates a very novel and exciting mechanism of TGR-1202, that is unique to TGR-1202 as opposed to other PI3K delta inhibitors and could have broad ranging implications for certain combinations in both liquid and solid tumors," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. He continued, "We are looking forward to sharing the full datasets for these presentations in a few weeks, which will contain more detailed data and additional patients than included in the abstracts."

Presentations on TG-1101 and TGR-1202 at the ASH (Free ASH Whitepaper) meeting include the following:

Clinical Posters:

Title: Ublituximab + TGR-1202 Demonstrates Activity and Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results
Abstract Number: 1538
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster I
Date and Time: Saturday, December 5, 2015; 5:30 PM- 7:30 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Matthew Lunning, DO

Title: A Phase I Trial of TGR-1202, a Next Generation Once Daily PI3K-Delta Inhibitor in Combination with Obinutuzumab Plus Chlorambucil, in Patients with Chronic Lymphocytic Leukemia
Abstract Number: 2942
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 6, 2015; 6:00 PM-8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Daruka Mahadevan, MD, PhD

Title: Ublituximab (TG-1101), A Novel Glycoengineered Anti-CD20 Monoclonal Antibody, in Combination With Ibrutinib is Highly Active in Patients With Relapsed And/Or Refractory Mantle Cell Lymphoma; Results of a Phase II Trial
Abstract Number: 3980
Session: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Kathryn Kolibaba, MD

Title: TGR-1202, a Novel Once Daily PI3K-Delta Inhibitor, Demonstrates Clinical Activity with a Favorable Safety Profile in Patients with CLL and B-Cell Lymphoma
Abstract Number: 4154
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 7, 2015; 6:00 PM- 8:00 PM ET
Location: Orange County Convention Center, Hall A
Presenter: Owen O’Connor, MD, PhD

Non-Clinical Oral Presentation:

Title: Disruption of the mTOR-eIF4F Axis By Selectively Targeting PI3Kdelta and Proteasome Potently Inhibits Cap Dependent Translation of c-Myc in Aggressive Lymphomas
Abstract Number: 593
Oral Session: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Novel Therapies and Targets in Lymphoma
Date and Time: Monday, December 7, 2015; 10:30 AM – 12:00 PM ET
Presentation Time: 11:30 AM ET
Location: Orange County Convention Center, Tangerine 1 (WF1)
Presenter: Changchun Deng, MD, PhD

A copy of the above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org.

TG Therapeutics will also host a reception on Monday, December 7th, 2015 beginning at 7:45pm ET, with featured presentations beginning promptly at 8:00pm ET. The event will take place at the Hyatt Regency Orlando. This event will be webcast live and will be available on the Events page, under the Investors & Media tab, of the Company’s website at www.tgtherapeutics.com.

On November 5, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2015 (Press release, Sunesis, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107168 [SID:1234507998]). Loss from operations for the three and nine months ended September 30, 2015 was $8.6 million and $28.0 million, respectively. As of September 30, 2015, cash, cash equivalents and marketable securities totaled $30.5 million.

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"We continue to work diligently to complete and submit an MAA by year end for approval of vosaroxin in Europe as a treatment for AML," said Daniel Swisher, Chief Executive Officer of Sunesis. "We believe the European market opportunity is significant, and remain encouraged by the strong support from within the international AML investigator community to bring this important new therapy to a patient population that has seen little improvement in treatment standards in the last 40 years. While this effort remains our central priority, we are also carefully evaluating and refining our plans to gain marketing approval in the U.S., and working toward key milestones with our kinase inhibitor pipeline, including data at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC Conference followed by an upcoming CTA filing and Phase 1 study for SNS-062 in Europe."

Third Quarter 2015 Highlights

Received European regulatory guidance regarding potential marketing authorization application for Vosaroxin in AML and Announced Expected Submission of MAA Filing before Year End. 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. In October, the company confirmed that it intends to submit an MAA for vosaroxin by the end of 2015.

Announced Poster Presentation of VALOR Responder Survival Analysis at the Chemotherapy Foundation Symposium. Yesterday, Sunesis announced that results from a responder survival analysis of the VALOR trial were presented in a poster presentation at the 2015 Chemotherapy Foundation Symposium (CFS) in New York City. The analysis examined the impact of complete remission status on overall survival. Results showed that CR status was the strongest independent predictor of overall survival in patients enrolled in the study, regardless of study arm, with median survival for patients in CR lasting more than 12 months longer than patients without a CR. Furthermore, the addition of vosaroxin to cytarabine demonstrated a two-fold increase in CR rate by day 60. The CR benefit conveyed by vosaroxin was consistently beneficial across all pre-specified subgroups, including in patients with the high unmet medical need, such as those over 60 years of age and those with refractory or relapsed disease. The poster presentation, titled "Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial," will be available at www.sunesis.com following the conclusion of the symposium.

Announced Presentations at the Upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). Sunesis recently announced that two poster presentations from the company’s proprietary kinase inhibitor programs will be presented at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place November 5-9 in Boston, Massachusetts. The presentations on November 8th will include preclinical data from the company’s selective PDK1 inhibitors SNS-229 and SNS-510, as well as the company’s potent noncovalent second-generation BTK inhibitor, SNS-062.

Announced Oral Presentation of VALOR Analysis at the 77th Annual Meeting of the Japanese Society of Hematology. In October, Sunesis announced that data from an analysis of the company’s VALOR trial, evaluating vosaroxin in older patients with AML, were presented at the AML Clinical Trial Oral Session of the 77th Annual Meeting of the Japanese Society of Hematology (JSH) in Kanazawa, Japan. The data presented at JSH, which show a compelling survival benefit, durable responses and tolerability profile in patients age 60 years and older, were first presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress in June 2015.

Announced Publication of Vosaroxin Phase 3 VALOR Trial Results in The Lancet Oncology. In August, Sunesis announced that results from the company’s Phase 3 VALOR trial were published in The Lancet Oncology. The article, titled "Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study" is available online and appeared in the September 2015 print issue of The Lancet Oncology. The published results describe how although overall survival (OS) did not reach a significant difference based on the primary unstratified log-rank analysis of the endpoint, vosaroxin plus cytarabine, based on other prespecified analyses did show an overall survival benefit in relapsed/refractory AML, with the greatest benefit observed in patients older than 60 years, a population with limited treatment options.

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.

Financial Highlights
Cash, cash equivalents and marketable securities totaled $30.5 million as of September 30, 2015, as compared to $43.0 million as of December 31, 2014. The decrease of $12.5 million was primarily due to $29.5 million of net cash used in operating activities and $1.6 million of principal payments against notes payable, partially offset by $18.6 million raised from the sale of common stock through the company’s at-the-market facility with Cantor Fitzgerald & Co. and from option exercises. This capital is expected to be sufficient to fund the company to the middle of 2016.

Revenue for the three and nine months ended September 30, 2015 was $0.7 million and $2.4 million as compared to $0.9 million and $4.8 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 $5.3 million and $16.1 million for the three and nine months ended September 30, 2015 as compared to $6.9 million and $21.7 million for the same periods in 2014. The decreases between the comparable three and nine month periods were primarily due to reductions in clinical trial expenses, consulting and other outside services costs in each case.

General and administrative expense was $4.0 million and $14.3 million for the three and nine months ended September 30, 2015 as compared to $7.2 million and $17.0 million for the same periods in 2014. The decreases between the comparable three and nine month periods were primarily due to decreases in outside services and personnel costs.

Interest expense was $0.2 million and $0.7 million for the three and nine months ended September 30, 2015 as compared to $0.4 million and $1.4 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 $1.8 million and $3.6 million for the three and nine months ended September 30, 2015 as compared to net other expense of $1.6 million and $6.4 million 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, which expired in October 2015.

Cash used in operations was $29.5 million for the nine months ended September 30, 2015 as compared to $34.2 million for the same period in 2014. Net cash used in the 2015 period resulted primarily from the net loss of $25.1 million and changes in operating assets and liabilities of $5.6 million, partially offset by net adjustments for non-cash items of $1.2 million.

Sunesis reported loss from operations of $8.6 million and $28.0 million for the three and nine months ended September 30, 2015 as compared to $13.3 million and $33.9 million for the same periods in 2014. Net loss was $7.0 million and $25.1 million for the three and nine months ended September 30, 2015 as compared to $15.3 million and $41.7 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.

On November 5, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported one oral presentation and two poster presentations at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 5-8 in Orlando, Florida (Press release, Sunesis, NOV 5, 2015, View Source;p=RssLanding&cat=news&id=2107396 [SID:1234507997]).

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The details for the oral presentation are as follows:

Date and Time: Monday, December 7, 2015 at 8:00 a.m. Eastern Time
Abstract Title: Phase I/II Study of Vosaroxin and Decitabine in Newly Diagnosed Older Patients (pts) with Acute Myeloid Leukemia (AML) and High Risk Myelodyplastic Syndrome (MDS)
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: New Epigenetic Approaches
Publication Number: 461
Location: Orange County Convention Center, W109

The full abstract can be viewed here.

The details for the poster presentations are as follows:
Date and Time: Saturday, December 5, 2015 from 6:00 p.m. to 8:00 p.m. Eastern Time
Abstract Title: Baseline Predictors of Mortality in Patients with Relapsed or Refractory Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine in the Phase 3 VALOR Study
Session Number: 616
Session Name: Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Publication Number: 2560
Location: Orange County Convention Center, Hall A

The full abstract can be viewed here.

Date and Time: Saturday, December 5, 2015 from 5:30 p.m. to 7:30 p.m. Eastern Time
Abstract Title: A Phase I Study of Vosaroxin Plus Azacitidine for Patients with Myelodysplastic Syndrome
Session Number: 637
Session Name: Myelodysplastic Syndromes – Clinical Studies: Poster I
Publication Number: 1686
Location: Orange County Convention Center, Hall A

The full abstract can be viewed here.