1stOncology™: Cancer Intelligence Service – Page 16046 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ZIOPHARM Reports Second-Quarter 2015 Financial Results and Recent Activities

On August 10, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported financial results for the second quarter ended June 30, 2015, and provided an update on the company’s recent activities (Press release, Ziopharm, AUG 10, 2015, View Source [SID:1234507193]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"ZIOPHARM continues to make important headway, both in the lab and clinic, in the development of our novel gene and adoptive cell therapy programs and technologies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "This includes advancement of several chimeric antigen receptor (CAR) and T-cell receptor (TCR) candidates toward the clinic, evolution of the Sleeping Beauty non-viral gene transfer platform, integration of RheoSwitch technology into various adoptive cell therapies and clinical strategies for controlled delivery of IL-12 using adenovirus. Working with Intrexon and our other partners, we look forward to advancing these cancer immunotherapies, and to presenting early data from across these platforms prior to the end of this year."

Recent Highlights

Ad-RTS-hIL-12

Ad-RTS-hIL-12 is a gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. In April 2015, ZIOPHARM announced the initiation of a Phase 1b/2 study of Ad-RTS-hIL-12 and veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. In May 2015, the Company announced the initiation of a multi-center Phase 1 study of Ad-RTS-hIL-12 and veledimex in patients with recurrent or progressive glioblastoma multiforme, a form of brain cancer.

Both gene therapy trials, which are being conducted at leading centers across the U.S., are currently open and accruing patients. The Company expects that early results from each study will be presented at scientific meetings prior to year end.

ZIOPHARM also announced in July that the U.S. Food and Drug Administration granted Orphan Drug Designation for Ad-RTS-hIL-12 and veledimex in the treatment of patients with malignant glioma. The FDA’s Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.

Adoptive Cell Therapies

In March 2015, ZIOPHARM and its partner Intrexon (NYSE:XON) announced a global collaboration focused exclusively on novel chimeric antigen receptor T-cell (CAR-T) products with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. Under terms of the agreement, Intrexon will share the economic provisions of the collaboration, including an upfront payment, milestones and royalties, equally with ZIOPHARM. On July 31, 2015, ZIOPHARM received $57.5 million from Intrexon related to the upfront payment.

The collaboration’s first two CAR-T targets of interest were recently selected, and Intrexon and ZIOPHARM have initiated research and development efforts on these programs. The specific targets were not disclosed. Under the terms of the agreement, ZIOPHARM and Intrexon will also independently conduct research and development on other CAR-T candidates, with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, having the opportunity to opt-in during clinical development.

ZIOPHARM’s other oncology programs, including those related to TCR and natural killer (NK) cells, continue to advance independently under its Exclusive Channel Collaboration (ECC) with Intrexon.

ZIOPHARM expects that results from its adoptive cell therapy programs, including data highlighting the advancement of the Sleeping Beauty non-viral gene transfer technology, will be presented at medical and scientific meetings prior to year end.

Corporate

In May 2015, ZIOPHARM announced the appointment of Dr. Cooper to the role of Chief Executive Officer. Dr. Cooper brings extensive experience in pioneering the development of adoptive cellular therapies in the field of oncology and translating immunology into clinical practice. Dr. Cooper joined ZIOPHARM from the University of Texas MD Anderson Cancer Center, where his appointments included tenured professor Pediatrics and Immunology; Section Chief Cell Therapy, Children’s Cancer Hospital; and Associate Director, Center for Cancer Immunology Research. Dr. Cooper is now a Visiting Scientist at MD Anderson.

In June 2015, the Company announced that Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary, had been appointed to the added role of Chief Operating Officer. Mr. Belbel joined ZIOPHARM Oncology in September 2011 as Executive Vice President and Chief Legal Officer. Mr. Belbel has over 25 years of experience in senior operational and corporate roles, with expertise in corporate strategy and management, mergers, acquisitions, divestitures and public and private financings.

Second-Quarter 2015 Financial Results

Net loss for the second quarter of 2015 was $14.2 million, or $(0.11) per share, compared to a net loss of $5.6 million, or $(0.06) per share, for the second quarter of 2014. Included in the loss for the second quarter of 2014 was non-cash income of $5.6 million, or $(0.06) per share for the change in fair value of warrants.

Research and development expenses were $7.4 million for the second quarter of 2015 compared to $8.3 million for the second quarter of 2014. The decrease of $0.9 million in research and development expenses is primarily attributable to reduced employee related and clinical study costs.

General and administrative expenses were $7.0 million for the second quarter of 2015 compared to $3.0 million for the second quarter of 2014. The increase of $4.0 million in general and administrative expenses is primarily attributable to non-cash equity compensation and other employee related expenses.

The Company ended the quarter with cash and cash equivalents of approximately $118.6 million. In addition, on July 31, 2015, the Company received $57.5 million from Intrexon related to the Merck Serono agreement. Given current development plans, the Company anticipates that current cash resources, including the recent cash payment received from Intrexon pursuant to the Merck Serono collaboration, will be sufficient to fund our planned operations into the first quarter of 2018.

Verastem Reports Second Quarter 2015 Financial and Corporate Results

On August 10, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported financial results for the second quarter ended June 30, 2015, and also provided an overview of certain corporate accomplishments and plans (Press release, Verastem, AUG 10, 2015, View Source;p=RssLanding&cat=news&id=2078274 [SID:1234507190]).

"Execution of the ongoing COMMAND trial continues to progress well and we remain on track to report the outcome of the interim analysis during the third quarter of 2015," said Robert Forrester, President and Chief Executive Officer of Verastem. "The independent Data and Safety Monitoring Board (DSMB) will examine pre-specified efficacy and safety data sets to decide whether to recommend continuation in all patients as planned, or to enrich the study population based upon merlin status, or to stop the study early for futility. This will be an important milestone for Verastem."

Q2 2015 and Recent Highlights

VS-6063 (Focal Adhesion Kinase Inhibition)

COMMAND (Control Of Mesothelioma with MAinteNance Defactinib) Study

Registration-directed, randomized, double-blind, placebo-controlled study of VS-6063 as a switch maintenance treatment in patients with malignant pleural mesothelioma benefiting from frontline therapy with pemetrexed (Alimta) and platinum
Co-primary endpoints are Progression Free Survival (PFS) and Overall Survival (OS). The study is designed to provide 90% power to assess the superiority of PFS, with a 1 sided type I error rate of 0.025, assuming a hazard ratio of 0.67
308 patients enrolled at 72 centers in 15 countries as of August 6, 2015
Interim analysis to define the primary patient population anticipated in Q3 2015

Presentations and Publications
Reported encouraging scientific data in support of Verastem’s cancer stem cell inhibitors (VS-6063, VS-4718, and VS-5584) in multiple tumor types, including mesothelioma, small cell lung cancer, breast cancer, and hematologic malignancies, at the 2015 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Copies of the presentations can be accessed at: http://bit.ly/12otlcV

Corporate
Appointed Lou Vaickus, MD, FACP as Interim Chief Medical Officer
Hosted an analyst and investor event at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Guest speakers Professor Dean Fennell, Ph.D., FRCP, and Max Wicha, M.D., gave presentations on mesothelioma and the rationale and importance of targeting cancer stem cells through FAK inhibition

Upcoming Clinical Milestones
Verastem’s anticipated upcoming data milestones include:

VS-6063

COMMAND interim analysis: Q3 2015
Phase 2 results in KRAS-mutated NSCLC at the World Conference of Lung Cancer in Denver, CO on September 6-9th
Updated results from the VS-6063/paclitaxel combination in patients with ovarian cancer: H2 2015
Biomarker "Window of Opportunity" mesothelioma study with preliminary results from the extended treatment cohort: H1 2016

VS-4718
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

VS-5584
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

Second Quarter 2015 Financial Results
As of June 30, 2015, Verastem had cash, cash equivalents and investments of $132.1 million compared to $92.7 million as of December 31, 2014. Verastem used $12.0 million for operating activities in the second quarter ended June 30, 2015 (the "2015 Quarter").

Net loss for the 2015 Quarter was $15.4 million, or $0.42 per share, as compared to net loss of $13.0 million, or $0.51 per share, for the same period in 2014 (the "2014 Quarter"). Net loss includes stock-based compensation expense of $2.6 million and $3.2 million for the 2015 Quarter and 2014 Quarter, respectively.

Research and development expense for the 2015 Quarter was $11.0 million compared to $8.3 million for the 2014 Quarter. The $2.7 million increase from the 2014 Quarter to the 2015 Quarter was primarily related to an increase of $2.1 million in contract research organization expense for outsourced biology, development and clinical services, which includes Verastem’s clinical trial costs, and an approximate $732,000 increase in personnel costs. These increases were partially offset by a decrease in stock-based compensation expense of approximately $162,000.

General and administrative expense for the 2015 Quarter was $4.4 million compared to $4.8 million for the 2014 Quarter. The $400,000 decrease was primarily due to a decrease in stock-based compensation expense.
There were 36,853,805 common shares outstanding as of June 30, 2015.

Financial Guidance
Based on current operating plans, the Company expects to have sufficient cash, cash equivalents and investments to fund its research and development programs and operations into the first half of 2017.

About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a "Window of Opportunity" study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.

About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

TG Therapeutics, Inc. Announces Second Quarter 2015 Financial Results and Business Update

On August 10, 2015 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2015 and recent company developments (Press release, TG Therapeutics, AUG 10, 2015, View Source [SID:1234507189]).

Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "The second quarter was a busy and exciting time for the Company, as the data presentations made during the quarter continue to reinforce our belief that the safety and efficacy profiles of TG-1101 and TGR-1202, alone or in combination together in our "1303" regimen, allow for safe and efficacious multiple drug regimens, which we firmly believe is the future of patient care in the treatment of B-cell malignancies. We remain focused on commencing additional combination registration trials in the coming months, and aggressively recruiting into our ongoing GENUINE Phase 3 clinical trial." Mr. Weiss continued, "From a financial perspective, with cash on hand of more than $125 million on a pro forma basis, we are well positioned to execute on our goals and bring the Company to substantial value creating milestones."

Recent Developments and Highlights

Clinical data on the combination of TG-1101 and TGR-1202 was presented at the 51st American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago, Illinois, as well as in poster presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting held in Vienna, Austria and the International Congress on Malignant Lymphoma (ICML), held in Lugano, Switzerland

Single agent clinical data for TGR-1202 was presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, as well as in oral presentations at the EHA (Free EHA Whitepaper) and Lugano ICML meetings

Clinical data on the triple combination of TG-1101, TGR-1202, and ibrutinib was presented in an oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, and in an oral presentation at the Lugano ICML meeting

Updated results from a Phase 2 clinical trial of TG-1101 in combination with ibrutinib in relapsed/refractory Chronic Lymphocytic Leukemia (CLL) was presented in an oral presentation at the Lugano ICML meeting

Presently have over 120 sites open for the Company’s GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib in patients with High-Risk Chronic Lymphocytic Leukemia
Reaffirming 2015 Milestones

Continue to aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib
Commence additional combination Phase 3 clinical trials, particularly for the Company’s proprietary "1303" combination of TG-1101 plus TGR-1202 in patients with Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin’s Lymphoma (NHL)
Launch new triple therapy combination trials in addition to the currently enrolling Phase 1/2 trial of TG-1101 plus TGR-1202 plus ibrutinib

Continue to push forward our preclinical development programs, including the IRAK4, anti-PD-L1, and anti-GITR programs, as well as opportunistically seek to identify drug candidates with complimentary mechanisms of action
Commence clinical development program for the treatment of autoimmune diseases

Present updated data on Phase 1 and 2 clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in December 2015, held in Orlando, Florida

Financial Results for the Second Quarter 2015

At June 30, 2015 the Company had cash, cash equivalents, investment securities, and interest receivable of $110.6 million, which includes approximately $51.2 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the year (approximately $42 million of which was previously disclosed in connection with our last quarterly update), as compared to December 31, 2014 when we had $78.9 million.

Pro-forma cash, cash equivalents, investment securities, and interest receivable as of June 30, 2015 are approximately $126.4 million, including $15.8 million of net proceeds from the utilization of the ATM sales facility during the third quarter of 2015.

Our consolidated net loss for the second quarter ended June 30, 2015, excluding non-cash items, was approximately $10.9 million, which included approximately $4.8 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the second quarter ended June 30, 2015, inclusive of non-cash items, was $17.1 million, or $0.38 per diluted share, compared to a consolidated net loss of $12.0 during the comparable quarter in 2014, representing an increase in consolidated net loss of $5.1 million. The increase in consolidated net loss during the second quarter ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $5.8 million and $1.3 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs. These increases were partially offset by the $1.2 million of non-cash stock expense recorded in conjunction with the license to the IRAK4 inhibitors program during the quarter ended June 30, 2014 and a decrease of $1.5 million in non-cash compensation expense related to equity incentive grants over the comparable period in 2014.

Our consolidated net loss for the six months ended June 30, 2015, excluding non-cash items, was approximately $20.1 million, which included approximately $9.1 million of manufacturing and CMC expenses in preparation for Phase 3 clinical trials and commercialization. The consolidated net loss for the six months ended June 30, 2015, inclusive of non-cash items, was $31.7 million, or $0.73 per diluted share, compared to a consolidated net loss of $19.5 million during the comparable period in 2014, representing an increase in consolidated net loss of $12.2 million. The increase in consolidated net loss during the six months ended June 30, 2015 was primarily the result of other research and development expenses for TG-1101 and TGR-1202 increasing approximately $9.8 million and $2.5 million, respectively, over the comparable period in 2014. The increase in other research and development expenses related to TG-1101 was primarily the result of increased manufacturing and clinical trial expenses related to ongoing and planned future Phase 3 registration programs.

8-K – Current report

On August 10, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, provided a corporate update and reported financial results for the quarter ended June 30, 2015 (Filing, 8-K, Telik, AUG 10, 2015, View Source [SID:1234507187]).

"We are reporting progress toward achieving our near-term drug development milestones and with our capital formation," stated MabVax’s President and Chief Executive Officer David Hansen. "We completed a $11.7 million equity financing led by OPKO Health, Inc., and its Chairman and Chief Executive Officer, biotech investor and entrepreneur Dr. Phillip Frost, which put MabVax in one of the best financial positions in our corporate history. We finished the second quarter with approximately $7.2 million in cash and equivalents, including the release on June 30, 2015, of $3.5 million of funds from the equity financing to the Company that were being held in escrow by OPKO Health, Inc. and Frost Gamma Investment Trust. We believe that our current cash position is sufficient to support our near-term drug discovery and development efforts."

"The encouraging results from our non-human primate safety study for HuMab 5B1 further support our plan to file two Investigational New Drug applications, or INDs, with the FDA by 2015 year-end and begin both clinical trials in the first quarter of 2016," he added. "The GMP manufacturing of our clinical supplies of HuMab 5B1-based product for both clinical trials is on track for delivery in the fourth quarter of this year."

MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

Second Quarter and Recent Highlights

Significant financing transaction with a leading investor – April 10, 2015 – closed on approximately $11.7 million in a private placement led by OPKO Health, Inc. and its Chairman and CEO Dr. Phillip Frost. On June 30, 2015, OPKO Health, Inc. and Frost Gamma Investment Trust investments in the aggregate of $3.5 million associated with the financing were released from escrow.

Encouraging results of non-human primate toxicology study – On May 5, 2015, announced results from non-GLP toxicology testing of HuMab 5B1 antibody completed by a leading independent contract research organization. These results detailed that the antibody, administered in either a single dose or repeated doses, produced no significant adverse findings even at the highest dosage levels tested. Non-human primates in this acute dose range finding study were challenged with multiple dose levels to assess drug pharmacokinetics, as well as with repeated doses of the antibody to identify any adverse toxicology signals. These studies were conducted in the most relevant animal models with material produced by the Company’s GMP manufacturing partner. The antibody as tested is representative of the clinical supply material scheduled for delivery later this year for the planned Phase I clinical trials.

Rockefeller University Collaboration – In July 2015, entered into a research collaboration agreement to supply Rockefeller University’s Laboratory of Molecular Genetics and Immunology with antibody material to explore the mechanism of action of constant region (Fc) variants of the HuMab 5B1 in the role of tumor clearance. The Company will supply additional research materials as requested by the university, which is evaluating ways to optimize the function.

Second Quarter 2015 Financial Results

• Grant revenues totaled approximately $137,000.

• Research and development expenses were $2.3 million.

• General and administrative expenses totaled approximately $4.2 million.

• Net loss for the quarter was $6.4 million, or $0.29 per share, on approximately 25.2 million shares of common stock outstanding.

• Completed $11.7 million financing including the release of $3.5 million in funds held in escrow.

• At June 30, 2015, cash and cash equivalents totaled $7.2 million.

About HuMab 5B1

In pre-clinical research, MabVax’s HuMab 5B1 antibody has demonstrated high specificity, affinity and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the therapeutic product.

Stemline Therapeutics Reports Second Quarter 2015 Financial Results

On August 10, 2015 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical stage biopharmaceutical company developing novel oncology drugs that primarily target cancer stem cells (CSCs) and tumor bulk, reported financial results for the quarter ended June 30, 2015 (Press release, Stemline Therapeutics, AUG 10, 2015, View Source [SID:1234507184]).

Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "This quarter, we began enrollment in the expansion stage of our SL-401 pivotal trial in BPDCN, a highly aggressive malignancy of unmet medical need. This follows completion of the lead-in stage of this trial, wherein we evaluated multiple cycle SL-401 administration at escalating doses in first-line and relapsed/refractory BPDCN as well as relapsed/refractory AML. In the lead-in, we established a dose and schedule for the expansion stage, and observed major objective responses, including complete responses, some with gross clearance of bulky disease in multiple organ systems in BPDCN. We are encouraged by both the lack of cumulative side effects and cases of ongoing efficacy seen thus far with multiple cycles. The expansion stage focuses on relapsed/refractory BPDCN patients, which we believe could support registration. We look forward to updating and reporting detailed data at upcoming medical conferences."

Dr. Bergstein continued, "With the expansion stage of our BPDCN pivotal trial underway, we continue to pursue additional opportunities to expand SL-401’s potential in other malignancies, and have opened trials in early and late stage AML and high-risk myeloproliferative neoplasms. We also continue to advance and position our other pipeline candidates, SL-701 and SL-801. With a strong cash position and multiple programs advancing in a variety of indications, we remain well positioned to achieve our objective of building a leading commercial stage biopharmaceutical company."

Second Quarter 2015 Financial Results Review

Stemline ended the second quarter of 2015 with $109.0 million in cash, cash equivalents and investments, as compared to $58.6 million as of December 31, 2014. In the first quarter of 2015, the Company completed an equity offering raising $68.6 million in gross cash proceeds on the sale of 4.4 million common shares.

For the second quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.0 million, or $0.47 per share, for the same period in 2014.

Research and development expenses were $8.2 million for the second quarter of 2015, which reflects an increase of $4.1 million compared with $4.1 million for the second quarter of 2014. The higher expenses during the second quarter were primarily attributable to the SL-401 clinical program due largely to the ramp up of patient accrual.

General and administrative expenses were $2.2 million for the second quarter of 2015, which reflects an increase of $0.2 million compared with $2.0 million for the second quarter of 2014. The higher costs were primarily attributable to an increase in stock based compensation expense relating to administrative employees.