On November 11, 2015 DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported data on the potential of VAL-083 (dianhydrogalactitol) as a new chemotherapy treatment for malignant pediatric brain tumors (Press release, DelMar Pharmaceuticals, NOV 11, 2015, View Source [SID:1234508202]).

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The Company presented the data in a poster entitled, "Dianhydrogalactitol (VAL-083) Offers Potential Therapeutic Alternatives in the Treatment of Pediatric Brain Tumors," at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Pediatric Research: From Mechanisms and Models to Treatment and Survivorship conference on Tuesday, November 10, 2015.

"We believe that VAL-083 may be an effective chemotherapeutic alternative for pediatric brain tumors," stated Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals. "Based on an analyses of historical clinical trials sponsored by the U.S. National Cancer Institute and DelMar’s recent clinical and preclinical data, the Company sought to further investigate the cytotoxic activity of VAL-083 against resistant forms of pediatric medulloblastoma and pediatric high grade gliomas cell lines, in vitro."

The data analyses and the in vitro study results detailed in the poster demonstrate that:

VAL-083 has historical activity in childhood refractory medulloblastoma (MB) and glioblastoma multiforme (GBM);
VAL-083 overcomes MGMT-related temozolomide (TMZ) resistance in GBM cancer stem cells and non-cancer stem cells cancer stem cells (CSCs) and non-CSCs;
VAL-083 is active against medulloblastoma cells with SHH characteristics and p53 mutations; and
VAL-083 in combination with TMZ completely inhibits self-renewal of pediatric GBM cancer stem cells (CSCs).
"The compilation of these data and our recent compelling in vitro results in pediatric MB and HGG warrant the further in vitro research, which will serve as a basis for our clinical development strategy with VAL-083 in pediatric brain tumors," continued Mr. Bacha. "As the next step, we expect to establish discussions with leading clinical investigators in the field in order to undertake the necessary steps to advance VAL-083 into clinical studies as a potential treatment for children suffering from recurrent medulloblastoma or high grade gliomas."

Poster Summary

Medulloblastoma (MB) is the most common malignant pediatric brain tumor, accounting for 15-30% of all childhood intracranial neoplasms. High grade gliomas (HGG) are much rarer in children than in adults, comprising only 5%-10% of childhood brain tumors. Although multidisciplinary treatment has improved the 5-year survival rates in children significantly, the prognoses for recurrent MB and HGG remain poor with a median overall survival of less than one (1) year. Temozolomide (TMZ) is frequently employed in the treatment of MB and pediatric HGG; however, clinical evidence is lacking and poor outcomes due to high-expression of the repair protein O6-methylguanine-DNA methyltransferase (MGMT), which is correlated with TMZ resistance, have been reported.

VAL-083 is a structurally unique bi-functional alkylating agent, whose cytotoxic activity is due to the formation of DNA cross links at the N7. VAL-083 readily crosses the blood brain barrier and has been shown to accumulate in brain tumor tissue. The mechanism of VAL-083 is believed to be distinct from the mechanisms of other alkylating agents commonly used in the treatment of brain cancer (e.g. temozolomide, cisplatin or BCNU). DelMar has recently shown that VAL-083 overcomes TMZ-resistance and cisplatin-resistance, in vitro. VAL-083 has also demonstrated activity against medulloblastoma and glioma cell lines in vitro, including treatment-resistant GBM cancer stem cells (CSC).

In historical NCI-sponsored clinical studies, VAL-083 demonstrated clinical activity against medulloblastoma and high-grade gliomas. In these studies VAL-083 was investigated both as a stand-alone therapy and in combination with other chemotherapeutic regimens. VAL-083 demonstrated clinical activity in a range of brain tumor types, including MB and HGG. Additionally, data from one historical Phase II clinical trial in refractory MB, suggests a lack of cross-resistance between VAL-083 and common chemotherapeutic drugs used in MB treatment, and suggests VAL-083 may be valuable in chemo-resistant medulloblastoma and as part of a combination treatment.

More recently, DelMar has shown that VAL-083 demonstrates cytotoxic activity in glioblastoma (GBM) independent of MGMT expression in vitro and in vivo. Research has also shown that VAL-083 is highly effective against GBM cancer stem cells (CSC) and non-CSC and acts as a radiosensitizer in GBM cell lines, in vitro. Additionally, in the Company’s has recently reported promising data from its ongoing Phase II clinical trial in adult patients with recurrent GBM.

Summary of Proposed Clinical Trial

DelMar’s poster also outlined the company’s proposed clinical development strategy. Results of further in vitro research will be used to guide clinical strategy for development of VAL-083 as a potential new therapy for treatment of pediatric MB and pediatric HGG. The goal is to stratify patients based on their specific molecular subtype and target VAL-083-responsive difficult-to-treat tumors. However initially, VAL-083 will be tested in recurrent patients with MB or HGG.

"By focusing on ‘high-risk molecular’ patients stratified based on their molecular subtype, we hope to provide a new treatment option for difficult-to treat pediatric brain tumors such as HGG, and difficult-to-treat medulloblastoma sub-types including SHH patients with p53 mutations and group 3 tumors, ultimately providing a solution to a true unmet medical need," added Mr. Bacha.

Primary goal

To establish the maximum tolerated dose in children
Secondary goals

To estimate the efficacy of VAL-083, as measured by objective radiographic response
To evaluate progression-free survival (PFS) at 6 months
To evaluate median overall survival (OS)
To evaluate the safety profile of VAL-083 treatment
The poster presentation and other VAL-083 posters and scientific publications may be found on DelMar’s website under View Source

About VAL-083

VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia (CML) and lung cancer, and has received orphan drug designation in Europe and the U.S. for the treatment of malignant gliomas.

DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by the expression of MGMT, a DNA repair enzyme that is implicated in chemotherapy resistance and poor outcomes in GBM patients following standard front-line treatment with Temodar (temozolomide).

DelMar recently announced the completion of enrollment in a Phase II clinical trial of VAL-083 in refractory GBM. Patients have been enrolled at five clinical centers in the United States: Mayo Clinic (Rochester, MN); UCSF (San Francisco, CA) and three centers associated with the Sarah Cannon Cancer Research Institute (Nashville, TN, Sarasota, FL and Denver, CO).

In the Phase I dose-escalation portion of the study, VAL-083 was well tolerated at doses up to 40mg/m2 using a regimen of daily x 3 every 21 days. Adverse events were typically mild to moderate; no treatment-related serious adverse events reported at doses up to 40 mg/m2. Dose limiting toxicity (DLT) defined by thrombocytopenia (low platelet counts) was observed in two of six (33%) of patients at 50 mg/m2. Generally, DLT-related symptoms resolved rapidly and spontaneously without concomitant treatment, although one patient who presented with hemorrhoids received a platelet transfusion as a precautionary measure.

Sub-group analysis of data from the Phase I dose-escalation portion of the study suggested a dose-dependent and clinically meaningful survival benefit following treatment with VAL-083 in GBM patients whose tumors had progressed following standard treatment with temozolomide, radiotherapy, bevacizumab and a range of salvage therapies.

Patients in a low dose (≤5mg/m2) sub-group had a median survival of approximately five (5) months versus median survival of approximately nine (9) months for patients in the therapeutic dose (30mg/m2 & 40mg/m2) sub-group following initiation of VAL-083 treatment. DelMar reported increased survival at 6, 9 and 12 months following initiation of treatment with VAL-083 in the therapeutic dose sub-group compared to the low dose sub-group.

Further details can be found at View Source

Natural killer (NK) cells are increasingly considered as immunotherapeutic agents in particular in the fight against cancers. NK cell therapies are potentially broadly applicable and, different from their T cell counterparts, do not cause graft-versus-host disease. Efficacy and clinical in vitro or in vivo expansion of primary NK cells will however always remain variable due to individual differences of donors or patients. Long-term storage of clinical NK cell lots to allow repeated clinical applications remains an additional challenge. In contrast, the established and well-characterized cell line NK-92 can be easily and reproducibly expanded from a good manufacturing practice (GMP)-compliant cryopreserved master cell bank. Moreover, no cost-intensive cell purification methods are required. To date, NK-92 has been intensively studied. The cells displayed superior cytotoxicity against a number of tumor types tested, which was confirmed in preclinical mouse studies. Subsequent clinical testing demonstrated safety of NK-92 infusions even at high doses. Despite the phase I nature of the trials conducted so far, some efficacy was noted, particularly against lung tumors. Furthermore, to overcome tumor resistance and for specific targeting, NK-92 has been engineered to express a number of different chimeric antigen receptors (CARs), including targeting, for example, CD19 or CD20 (anti-B cell malignancies), CD38 (anti-myeloma) or human epidermal growth factor receptor 2 (HER2; ErbB2; anti-epithelial cancers). The concept of an NK cell line as an allogeneic cell therapeutic produced ‘off-the-shelf’ on demand holds great promise for the development of effective treatments.

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On November 11, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and nine-month periods ended September 30, 2015 (Press release, Eagle Pharmaceuticals, NOV 11, 2015, View Source [SID:1234508203]). Highlights of and subsequent to the third quarter of 2015 include:

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Entered into a co-promotion agreement with Spectrum Pharmaceuticals, under which Spectrum’s 32-person Corporate Accounts Sales Team, focused in the hematology and oncology space, will dedicate 80% of its time to marketing up to six Eagle products over the next 18 months. The agreement facilitates Eagle’s transition into a fully-commercial pharmaceutical company with limited commercial risk and minimal financial obligation. Eagle will also hire up to 20 Direct Sales Representatives as part of its long-term commercialization strategy;

Entered into an exclusive U.S. licensing agreement with Teikoku Pharma USA Inc. to market, sell and distribute Docetaxel Injection Concentrate, Non-Alcohol Formula, an investigational product intended for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer (PDUFA Date: December 26, 2015);

Successfully completed the clinical portion of its safety and efficacy study in September 2015 to evaluate RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (EHS). Based on preliminary study results, participants who received RYANODEX in combination with the Standard of Care1 showed no significant drug-related adverse events. Data analysis for the study is expected to be completed and released shortly;

The U. S. Patent and Trademark Office granted a new patent, expiring in March 2033, for the use of bendamustine hydrochloride (HCl) in a 50ml bag within ten minutes (the "rapid infusion" product). This new patent, along with three previously issued patents, further expands and protects Eagle’s bendamustine HCI intellectual property estate;

Product sales increased to $3.3 million compared to $0.9 million for the three months ended September 30, 2014;

Total revenue was $5.7 million compared to $2.8 million for the three months ended September 30, 2014;

Net loss was $10.2 million, or $0.65 per basic and diluted share, compared to a net loss of $9.1 million, or $0.65 per basic and diluted share, for the three months ended September 30, 2014; and

Cash, cash equivalents and short-term investments were $96.0 million at September 30, 2015.

"Eagle has accomplished a great deal already this year, and we remain focused on achieving our goals in the particularly exciting and important final weeks ahead," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "As we near the end of 2015 and enter 2016, there is the potential for us to have as many as four in-market products by May of next year."

"We are preparing for three important events at Eagle over the next several weeks, including reporting the results of our clinical study for RYANODEX in Exertional Heat Stroke shortly. Thereafter, we are awaiting approval of two products with December PDUFA dates: our rapidly infused bendamustine product, and our recently licensed Docetaxel Injection Concentrate, Non-Alcohol Formula, which has the potential to be the first alcohol-free docetaxel formulation approved in the US. Looking further ahead, we may receive approval of RTU bivalirudin in March 2016 and our tentatively approved liquid bendamustine in the 500ml bag on May 1st, 2016. Regarding rapidly infused bendamustine, we believe our commercial partner, Teva, will convert most or all of the market quickly in what we expect will be a promising launch in 2016. Regarding our other products, with a highly-talented commercial team now in place, we are able to capitalize on the exciting opportunities that lie ahead in order to deliver long term value to shareholders."

Third Quarter 2015 Financial Results

Total revenue for the three months ended September 30, 2015 was $5.7 million, as compared to $2.8 million for the three months ended September 30, 2014.

Product sales are primarily comprised of sales of RYANODEX, which was launched in August 2014, diclofenac-misoprostol, which was launched in January 2015, and sales of argatroban to two commercial partners. The latter also contributes royalty income. The $2.4 million increase in product sales in the third quarter of 2015 was driven by $0.7 million in net product sales of diclofenac-misoprostol (launched in January 2015), an increase of $1.0 million in net product sales of RYANODEX (launched in August 2014), and an increase in argatroban product sales of $0.7 million.

The $0.5 million increase in royalty income in the third quarter of 2015 reflects higher end-use sales of argatroban by our commercial partners.

Cost of revenues increased by $1.6 million to $3.8 million in the three months ended September 30, 2015 from $2.2 million in the three months ended September 30, 2014. This $1.6 million net increase resulted from $0.4 million in cost of revenue for diclofenac-misoprostol, an increase of $0.5 million in cost of revenue for RYANODEX due to increased product sales, and an increase of $0.7 million in argatroban cost of revenue due to increased product sales.

Research and development expenses were $6.9 million in the third quarter of 2015 as compared to $5.9 million in the three months ended September 30, 2014. The increase reflects an increase in project spending for the successful completion of the clinical treatment portion of the safety and efficacy study of RYANODEX (dantrolene sodium) for exertional heatstroke and an increase in project spending for Pemetrexed. The increased spending for these projects were offset by a decrease in project spending for bendamustine ready to dilute, 500ml and bendamustine rapid infusion due to the timing of research and development activities performed.

Selling, general and administrative expenses increased $1.6 million to $5.5 million in the third quarter of 2015, compared to $3.9 million in the three months ended September 30, 2014. This increase is related to a $0.4 million increase in professional fees, $1.4 million increase in selling, general and administrative salary and personnel related expenses, and $0.3 million increase in miscellaneous expenses offset by a $0.5 million decrease in marketing related to RYANODEX.

Net loss for the third quarter of 2015 was $10.2 million, compared to net loss of $9.1 million for the three months ended September 30, 2014, as a result of the factors discussed above.

Liquidity

As of September 30, 2015, the Company had $96.0 million in cash, cash equivalents and short-term investments; $196.0 million in additional paid in capital; and $87.6 million in stockholders’ equity.

On November 11, 2015 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, provided a corporate update and reported financial results for the third quarter ended September 30, 2015 (Press release, Onconova, NOV 11, 2015, View Source [SID:1234508209]).

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"Onconova continues to advance the development of rigosertib for the unmet needs of patients with myelodysplastic syndromes (MDS)," said Ramesh Kumar, Ph.D., President and CEO of Onconova. "Our pivotal Phase 3 INSPIRE trial is now open at multiple sites and we anticipate enrollment of the first patient shortly. This will mark an important step towards the approval of IV rigosertib as a treatment for higher-risk MDS (HR-MDS). We also look forward to presenting results from a Phase 2 trial of oral rigosertib in combination with azacitidine in MDS and acute myeloid leukemia (AML) patients at the 2015 ASH (Free ASH Whitepaper) Annual Meeting this December."

Recent Business Highlights:

Development of Rigosertib IV in Higher-Risk MDS (HR-MDS)

A Phase 3 clinical trial, referred to as INSPIRE, is now open at multiple sites in the United States. The INSPIRE trial is a randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, or failed to respond to, previous treatment with hypomethylating agents (HMAs). The trial will enroll approximately 225 patients randomized in a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated.

INSPIRE will be conducted in the United States, Europe, Australia, Israel, and Japan. The first patient in the INSPIRE trial is anticipated in 2015. Four U.S. sites have been activated and are screening patients. Clinical Trial Applications (CTAs) for INSPIRE have been filed in several European countries and the first CTA has been cleared by the Medicines and Healthcare Products Regulatory Agency in the U.K.

The INSPIRE study will be supported by Onconova’s rigosertib partners. Per the Company’s development and licensing agreement with Baxalta, Onconova’s commercialization partner in Europe, Baxalta will pay for half of the costs for the trial up to a specified cap. Onconova’s development and commercialization partner in Japan and Korea, SymBio Pharmaceuticals, Ltd., intends to participate in the trial by enrolling patients in Japan.

Development of Oral Rigosertib in Combination with Azacitidine for MDS and AML Patients

Onconova is approaching full enrollment in the Phase 2 portion of an open label Phase 1/2 clinical trial, designated 09-08, evaluating oral rigosertib in combination with the approved dose of injectable azacitidine for patients with HR-MDS and AML. The Phase 2 combination study includes both de novo patients (i.e. not previously treated with HMAs) and patients who failed treatment with a previous HMA.

Consistent with reported Phase 1 results, Bone Marrow Complete Responses (or BMCR), assessed by the International Working Group (or IWG) and Bone Marrow Blast (or BMBL) criteria, have been observed in a majority of the 18 currently evaluable MDS patients. These and additional data from Phase 2 patients yet to be evaluated are the subject of an oral presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Upcoming Events

Enrollment of the first patient in the Phase 3 INSPIRE trial: 4Q2015
Presentation of Phase 2 data from oral rigosertib combination trial in MDS and AML: 4Q2015
Analyst and investor KOL event in New York, NY to review results and discuss the path forward following the Phase 2 oral rigosertib combination trial in MDS and AML: 4Q2015
Publication of results from the HR-MDS ONTIME trial: 4Q2015
Enrollment of patients for the INSPIRE study in Europe and Japan: 1H2016

Third Quarter 2015 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2015 totaled $22.2 million, compared to $25.4 million as of June 30, 2015. During the third quarter, Onconova sold 1,940,103 shares through Cantor Fitzgerald for net proceeds of $4.7 million. On October 8, 2015, Onconova entered into a $16.5 million share purchase agreement and registration rights agreement with Lincoln Park Capital Fund. Upon signing the agreements, Lincoln Park Capital Fund made an initial purchase of 846,755 shares of the Company’s common stock for $1.5 million and received an additional 200,000 shares as consideration for entering into the purchase agreement.

Total net revenue was $1.6 million for the third quarter of 2015 and $1.9 million for the nine months ended September 30, 2015, compared to $0.1 and $0.7 million, respectively, for the comparable periods in 2014. Revenues in the third quarter of 2015 primarily consisted of contractual cost sharing revenue from Baxalta for the INSPIRE trial.

Research and development expenses were $5.3 million for the third quarter of 2015 and $21.3 million for the nine months ended September 30, 2015, compared to $11.9 and $39.0 million, respectively, for the comparable periods in 2014.
General and administrative expenses were $2.2 million for the third quarter of 2015 and $7.8 million for the nine months ended September 30, 2015, compared to $3.1 and $12.0 million, respectively, for the comparable periods in 2014.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer. Onconova’s clinical and pre-clinical stage drug development candidates are derived from its extensive chemical library and are designed to work against specific cellular pathways that are important in cancer cells, while causing minimal damage to normal cells. In addition to rigosertib, the Company’s most advanced product candidate, two other candidates are clinical stage, and several candidates are in pre-clinical stages. For more information, please visit View Source

About Rigosertib

Rigosertib is a small molecule that inhibits cellular signaling by acting as a Ras mimetic. This is believed to be mediated by direct binding of rigosertib to the Ras-binding domain (RBD) found in many Ras effector proteins, including the Raf kinases and PI3K. The initial therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia (AML). Clinical trials for rigosertib are being conducted at MDS Centers of Excellence in the United States, Europe, and the Asia-Pacific region. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the United States, Europe and Japan.

On November 10, 2015 Tokai Pharmaceuticals Inc. (NASDAQ: TKAI), a biopharmaceutical company focused on developing and commercializing innovative therapies for prostate cancer and other hormonally driven diseases, reported results for the quarter ended September 30, 2015 (Press release, Tokai Pharmaceuticals, NOV 10, 2015, View Source;p=RssLanding&cat=news&id=2110919 [SID:1234508183]).

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"This was an important quarter of progress for Tokai," said Jodie Morrison, President and Chief Executive Officer of Tokai. "Active screening of patients in our ARMOR3-SV pivotal trial is underway, and we expect to report top-line results by the end of 2016. In parallel, under the experienced leadership of Lisa Taylor, we are making substantial progress in shaping our go-to-market strategy and engaging with clinical leaders throughout the world who recognize the significant need for new treatment options for patients who are unresponsive to existing therapies."

Recent highlights include:

Pivotal ARMOR3-SV Trial Underway: During the quarter, Tokai began screening patients for participation in ARMOR3-SV, the company’s pivotal Phase 3 clinical trial of galeterone, the first Androgen Receptor Degrader in clinical testing. ARMOR3-SV, the first pivotal trial in prostate cancer employing a precision medicine approach for patient selection, is evaluating whether administration of galeterone results in a statistically significant increase in radiographic progression-free survival as compared to Xtandi (enzalutamide) in 148 treatment-naïve metastatic castration-resistant prostate cancer (mCRPC) patients whose prostate tumor cells express the androgen receptor splice variant-7 (AR-V7). AR-V7 is a truncated form of the androgen receptor that has been associated with non-response to commonly used oral therapies for mCRPC. The design of ARMOR3-SV is aligned with feedback obtained from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, and top-line data for the trial are expected by the end of 2016.

Expanded the Executive Team’s Commercial Expertise: Tokai continued to prepare its growing commercial organization for the anticipated launch of galeterone. Lisa Taylor joined the company during the quarter as Senior Vice President, Commercial Development, a newly created role. Ms. Taylor brings over two decades of experience in biopharmaceutical marketing, and was a member of the launch team for Xtandi (enzalutamide) at Medivation Inc.

Financial Results:

Cash and investments at September 30, 2015 were $73.1 million, compared to $105.3 million at December 31, 2014. Tokai believes that its existing cash and investments will be sufficient to enable the company to conduct ARMOR3-SV, fund the development of a companion diagnostic test for use with galeterone, conduct other clinical trials and nonclinical studies necessary to support the submission of an initial NDA to the FDA for galeterone, as well as to continue funding its operating expenses and capital expenditure requirements into the first half of 2017.

Research and development expense was $8.5 million and $24.9 million for the three and nine months ended September 30, 2015, respectively, as compared to $2.8 million and $10.8 million for the corresponding periods in 2014. The increases in research and development expense in both periods were primarily attributable to start-up costs for the ARMOR3-SV clinical trial and the development of the AR-V7 clinical trial assay, and costs associated with other clinical trial and manufacturing activities to support the submission of a new drug application for galeterone.

General and administrative expense was $3.4 million and $9.3 million for the three and nine months ended September 30, 2015, respectively, as compared to $3.6 million and $6.4 million for the corresponding periods in 2014. The increase in general and administrative expense for the nine month period primarily relates to increased headcount in general and administrative functions, increased legal and patent expenses and costs associated with operating as a public company since September 2014.
Net loss was $11.9 million and $34.1 million for the three- and nine-month periods ended September 30, 2015, respectively, as compared to $6.4 million and $17.1 million for the corresponding periods in 2014.