On August 9, 2016 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, reported financial results for the three and six months ended June 30, 2016 (Filing, Q2, Galectin Therapeutics, 2016, AUG 9, 2016, View Source [SID:1234514567]). These results are included in the Company’s Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Summary of Key Development Programs, Updates and Anticipated Milestones

• Completed recruitment in a Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with cirrhosis (stage 4) (the NASH-CX trial), wherein patient recruitment was completed slightly ahead of our original expectations

• Completed enrollment in Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis (stage 3) (the NASH-FX trial)

• Positive preclinical results were presented at the American Thoracic Society (ATS) 2016 International Conference in which GR-MD-02 had shown a positive effect on vascular remodeling in an animal model of pulmonary arterial hypertension (PAH)

• Presented interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis in which patients showed significant improvement in their plaque psoriasis

Management Commentary
"We are very pleased with the significant progress achieved this quarter completing enrollment in two important clinical trials, gaining further global protection of our intellectual property, and presenting further evidence of the positive effects of GR-MD-02 in new and exciting applications," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Most immediately, with enrollment in our NASH-FX trial in NASH patients with advanced fibrosis (stage 3) having been completed on schedule in May, we are on pace to report top-line data assessing the efficacy of GR-MD-02 by the end of September. And, with recruitment also completed for our Phase 2 NASH-CX trial, we will be able to assess the efficacy of GR-MD-02 in up to 156 patients with non-alcoholic steatohepatitis (NASH) with cirrhosis. Patient recruitment for this trial was completed slightly ahead of our original expectations and we anticipate to report top line results in December 2017, as previously planned."
With its NASH trials investigating liver applications, Galectin is also exploring other applications of its lead compound. This quarter, the Company received encouraging results on two early stage studies. In an early stage investigation of applicability to vascular remodeling in pulmonary arterial hypertension (PAH), investigators from the Vascular Biology Center and the Department of Pharmacology and Toxicology at Augusta University presented data at the American Thoracic Society (ATS) 2016 International Conference, in which GR-MD-02 had shown a positive effect in an animal model of PAH. David Fulton, Ph.D., director of the Vascular Biology Center at Augusta University, noted that the alterations in cardiopulmonary function and vascular proliferation, as well as in fibrosis were significantly attenuated by in vivo treatment with specific gal-3 inhibitors, with our lead compound obviously being a gal-3 inhibitor.
Separately, interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis, in which four patients who received 12 weeks of therapy had significant improvement in their plaque psoriasis, led to the extension of the treatment duration to 24 weeks. These interim results demonstrate a potentially important clinical effect of GR-MD-02 in clearing moderate-to-severe plaque psoriasis.

In the quarter, the Company also received Notice of Allowance from the Australian Government Patent Office for patent application for "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases" that, from the date they are issued and through 2032, will extend coverage of GR-MD-02 to Australia to treat patients at risk of non-alcoholic steatohepatitis (NASH), fibrosis, inflammatory and autoimmune disorders in which galectins are at least in part involved. The allowance of these claims further strengthens the protection of the intellectual property behind GR-MD-02. This is but one of more than 50 patent applications the Company has pending in 10 foreign countries, all of which are viewed as significant markets for the active pharmaceutical ingredient (API) or the manufacture of the API. When issued, this patent will augment Galectin’s current intellectual property portfolio for treatment of liver fibrosis, kidney fibrosis, lung fibrosis or heart fibrosis.
The investigator-sponsored trials utilizing GR-MD-02 in combination with checkpoint inhibitors being conducted by Galectin’s partners at the Providence Portland Cancer Center, who are also funding the studies, continue to advance. The study of GR-MD-02 in combination with Yervoy and Keytruda in two separate Phase 1b trials in patients with metastatic melanoma is expected to yield data from the Yervoy combination trial by the end of the year."
Galectin Therapeutics is exhibiting a steady pattern of progress throughout and across the organization not only with its primary investigations, but in new and evolving applications as well. As such, its addressable market increases from the still very large $35 billion, understood to be available just from the treatment of NASH, to an even larger sum when considering psoriasis, PAH and potentially other maladies. Each of these efforts is based on a very systematic approach to advancing development whereby Galectin is moving methodically along the development path while simultaneously branching out into adjacent and complementary markets whenever the science warrants a new investigation. Allied with very strong medical professionals who are conducting these trials and investigations, Galectin’s management team is doing everything within its power to optimize the value of the organization, its intellectual property, and the other assets at its disposal.
Financial Results
For the three months ended June 30, 2016, the Company reported a net loss applicable to common stockholders of $5.8 million, or $0.20 per share, compared with a net loss applicable to common stockholders of $4.9 million, or $0.21 per share, for the three months ended June 30, 2015. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program in NASH.

Research and development expense for the three months ended June 30, 2016 was $4.2 million, compared with $2.6 million for the three months ended June 30, 2015. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.
General and administrative expense for quarter was $1.3 million, compared with $2.1 million for the prior year, with the decrease being to severance and non-cash stock compensation and lower legal and accounting fees.
As of June 30, 2016, the Company had $18.0 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through June 30, 2017.

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On August 9, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three and six months ended June 30, 2016 (Press release, Vical, AUG 9, 2016, View Source [SID:1234514566]). Net loss for the second quarter of 2016 was $1.3 million, or $0.14 per share, compared with a net loss of $2.8 million, or $0.30 per share, for the second quarter of 2015. Revenues for the second quarter of 2016 were $4.1 million, compared with revenues of $4.2 million for the second quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under the ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.

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Vical had cash and investments of $38.5 million at June 30, 2016. This cash balance does not include the $7.8 million in proceeds received from the Company’s recently completed private placement. The Company’s net cash use for the first six months of 2016 was $3.5 million, which was consistent with the Company’s guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million, which includes the cash burn associated with the planned initiation of the HSV-2 Phase 2 clinical program later this year.

Operational updates include:

ASP0113 CMV Vaccine

Recruitment in the multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is nearing completion with over 90% of the subjects enrolled. Astellas expects enrollment to be completed during the third quarter of 2016, with the top-line data expected to be available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have made substantial progress in process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

One year follow up in the multinational Phase 2 trial in kidney transplant recipients is now complete. Astellas is completing the final verification of all outstanding data and expects to release the top-line trial results during the third quarter of 2016. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at 1 year after transplantation. The study also includes a key clinically relevant secondary endpoint, incidence of CMV disease.
HSV-2 Therapeutic Vaccine

Vical plans to initiate a Phase 2 trial of its bivalent HSV-2 therapeutic vaccine during the second half of 2016. The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of the vaccine in approximately 225 otherwise healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection. Vical is confirming with the FDA the Phase 2 trial design, which is intended to evaluate the vaccine’s efficacy using clinical relevant endpoints rather than virologic endpoints.
VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be completed by the end of 2016. Vical is working closely with its expert advisors and the FDA to design a Phase 2 efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis. This fungal infection is associated with a high rate of mortality in immunocompromised patients, and represents a sizeable unmet medical need for new antifungal therapies.
Equity Investment by AnGes

On August 1, 2016, Vical announced an agreement by AnGes, MG, a partner and shareholder in Vical since 2006, to purchase approximately $7.8 million of Vical’s common stock in a private placement. The shares were sold at a price of $4.24 per share, the 90-day volume weighted average price of Vical’s common stock and a premium to the close on the prior trading day. With the new investment, AnGes’ equity position increased to approximately 18.6% of Vical’s outstanding shares. The transaction further strengthens Vical’s relationship with AnGes, which has a strategic interest in DNA vaccines, including one in its own pipeline, and which has demonstrated an appreciation for Vical’s DNA technology, and clinical, regulatory, and manufacturing expertise over the years.

On August 9, 2016 Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported a corporate update and reported its financial results for the quarter ended June 30, 2016 (Press release, Portola Pharmaceuticals, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194332 [SID:1234514564]).

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"We made significant progress in the second quarter to advance our goal of commercializing multiple medicines that could change current medical practices for treating patients with thrombotic disorders and hematological cancers," said Bill Lis, chief executive officer of Portola. "We expect more milestone momentum in the remainder of this year as we prepare for the anticipated U.S. commercial launch of AndexXaTM, which is currently on track to be our first marketed product. As a potential universal antidote for Factor Xa inhibitor anticoagulants, AndexXa may fulfill an unmet need for a specific reversal agent for Factor Xa inhibitor-treated patients who suffer life-threatening bleeding. During the quarter, we also presented and published full results of the Phase 3 APEX study of betrixaban. We believe these results support its potential approval and use as the first anticoagulant for extended-duration blood clot prevention in acute medically ill patients. We expect to submit the betrixaban NDA to the FDA later this year. Finally, we enrolled the first patients in our Phase 2a study of cerdulatinib, and anticipate presenting data on this promising compound at a medical meeting later this year."

Recent Achievements, Upcoming Events and Milestones

AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the U.S. Food and Drug Administration (FDA)

Preparing for a U.S. commercial launch; PDUFA date of August 17, 2016, under an FDA Accelerated Approval pathway
Manufacturing of Generation 1 supply at CMC Biologics on track for commercial launch; plan to initiate validation campaign for Generation 2 long-term supply at Lonza
Enrollment remains on track for the Phase 3b/4 ANNEXA-4 study
ANNEXA-4 interim data to be presented in a late-breaking science session at ESC Congress on August 30
Plan to submit a Marketing Authorization Application (MAA) with the European Medicines Agency in the third quarter of 2016
Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients; designated Fast Track status by the FDA

Presented full results of the pivotal Phase 3 APEX study in a late-breaking clinical trial session at the ISTH SSC Meeting; simultaneously published online in The New England Journal of Medicine
Plan to submit a New Drug Application and an MAA later this year
Expect to present additional APEX data at upcoming medical conferences later this year
Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

Presented new pharmacokinetic and pharmacodynamic outcomes data from the completed Phase 1 study at the ASCO (Free ASCO Whitepaper) Annual Meeting
Presented final results of the Phase 1 study at the EHA (Free EHA Whitepaper) Congress
Initiated enrollment in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies
Expect to present initial Phase 2a data at a medical meeting later this year
Second Quarter 2016 Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee’s Pharmaceutical was $4.2 million for the second quarter of 2016 compared with $2.4 million for the second quarter of 2015. The increase in revenue was primarily due to a collaboration and license agreement that Portola entered into with BMS/Pfizer to develop and commercialize andexanet alfa in Japan and a clinical collaboration agreement that Portola entered into with Bayer to include its Factor Xa inhibitor in the andexanet alfa development program in Japan.

Total operating expenses for the second quarter of 2016 were $61.9 million compared with $61.2 million for the same period in 2015. Total operating expenses for the second quarter of 2016 included $7.6 million in stock-based compensation expense compared with $4.8 million for the same period in 2015.

Research and development expenses were $44.8 million for the second quarter of 2016 compared with $52.3 million for the second quarter of 2015. The decrease in research and development expenses was primarily due to lower development costs following the completion of enrollment in the APEX study of betrixaban and lower development costs related to cerdulatinib due to the timing of activities. These decreased costs were partially offset by an increase in costs to advance AndexXa and support early research programs.

Selling, general and administrative expenses for the second quarter of 2016 were $17.0 million compared with $8.9 million for the same period in 2015 as the Company increased headcount to support its growth and increased commercial launch preparation activities for AndexXa.

For the second quarter of 2016, Portola reported a net loss of $57.3 million, or $1.02 net loss per share, compared with a net loss of $58.3 million, or $1.12 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were approximately 56.4 million for the second quarter of 2016 compared with approximately 52.1 million for the same period in 2015.

As of June 30, 2016, cash, cash equivalents and investments totaled $353.6 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

On August 9, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported second quarter financial results (Press release, OncoMed, AUG 9, 2016, View Source [SID:1234514562]). As of June 30, 2016, cash, cash equivalents and short-term investments totaled $171.5 million.

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"With seven OncoMed-discovered drugs in fourteen clinical trials, we enter the second half of this year following the presentation of encouraging data from across our pipeline at the AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper) annual meetings," said Paul J. Hastings, Chairman and Chief Executive Officer. "In the next several months we expect to report additional Phase 1b data for vantictumab and ipafricept, our first-in-class Wnt inhibitors, as well as Phase 1 clinical data for our anti-DLL4/VEGF bispecific antibody and our first-in-class anti-RSPO3 antibody. As we approach the end of the year and enter into 2017, we look forward to significant milestones, including data from our PINNACLE and YOSEMITE randomized Phase 2 clinical trials, potential opt-ins totaling over $172 million in 2017 from our partnerships with GSK, Bayer and Celgene, and two IND filings for novel immuno-oncology agents."

Development Program Highlights

Presented data on four clinical-stage programs at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June
Initial Phase 1b safety and efficacy data for the company’s Wnt pathway inhibitors in combination with standard of care, vantictumab (anti-Fzd, OMP-18R5) in breast cancer and ipafricept (Fzd8-Fc, OMP-54F28) in ovarian cancer

Updated Phase 1b survival data for demcizumab (anti-DLL4, OMP-21M18) in non-small cell lung cancer (NSCLC) and for tarextumab (anti-Notch2/3, OMP-59R5) in small cell lung cancer

Completed enrollment of the dose escalation cohorts in the Phase 1b trial of demcizumab plus pembrolizumab (Keytruda)
Approximately ten patients each with second-line NSCLC, anti-PD1 refractory solid tumors or castrate-resistant prostate cancers are to be enrolled in the expansion cohorts

Presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2016 Annual Meeting in April for GITRL-Fc, anti-RSPO3 (OMP-131R10), vantictumab and demcizumab
Upcoming Milestones

Enrollment of the Phase 2 PINNACLE and YOSEMITE clinical trials expected to complete in the third quarter
Topline results from the PINNACLE study of tarextumab in small cell lung cancer expected by year-end 2016 or early 2017

Topline results from the YOSEMITE study of demcizumab in pancreatic cancer in the first-half of 2017

Presentations of Phase 1 data at upcoming medical conferences
Initial clinical data from the ongoing Phase 1b trials of vantictumab and ipafricept in combination with standard of care for the treatment of pancreatic cancer have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress being held October 7-11, 2016

Present first in-human data from ongoing Phase 1 clinical trials of anti-RSPO3 and the anti-DLL4/VEGF bispecific (OMP-305B83) this fall pending abstract acceptance

File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) before year-end for one of two immuno-oncology therapeutic candidates: IO#2, partnered with Celgene, or GITRL-Fc, a wholly owned asset
A second IND is expected to follow in the first half of 2017
Second Quarter 2016 Financial Results

Cash, cash equivalents and short-term investments totaled $171.5 million as of June 30, 2016, compared to $193.5 million as of March 31, 2016.

Revenues for the three months ended June 30, 2016 were $6.7 million, an increase of $2.0 million, compared to total revenue of $4.7 million for the three months ended June 30, 2015. This increase was primarily due to amortization of the $70.0 million safety milestone achieved in the fourth quarter of 2015.

Research and development (R&D) expenses were $29.7 million for the second quarter of 2016 compared with $22.0 million for the same period in 2015. Higher R&D expenditures during the second quarter 2016 were attributable to increased manufacturing and clinical costs for the Phase 2 demcizumab program, increased clinical costs for the Phase 1a/b anti-RSPO3 program, as well as IND-enabling manufacturing and toxicology costs for the IO#2 and GITRL-Fc programs.

General and administrative (G&A) expenses for the quarter ended June 30, 2016 were $4.8 million, compared to $4.3 million for the same period in 2015. Increased G&A costs during the second quarter 2016 were due to higher employee-related costs including stock-based compensation expenses.

Net loss for the second quarter 2016 was $27.7 million ($0.91 per share), compared to $21.6 million ($0.72 per share) for the same period of 2015. The change in net loss from the same quarter in 2015 was primarily due to an increase in research and development expenses.

On August 9, 2016 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, reported results for its third quarter ended June 30, 2016 (Press release, Ohr Pharmaceutical, AUG 9, 2016, View Source [SID:1234514559]).

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"The start of the Phase 3 registration program for Squalamine during the quarter marked a significant milestone in our overall development program for our lead drug candidate," said Jason Slakter, MD, Chief Executive Officer of Ohr. "There remains a significant need for new treatment options that can enhance visual acuity gains in wet AMD and provide a non-invasive treatment option. We believe that Squalamine, when administered as part of a combination therapy, meets these needs and has the potential to set a new standard of care. We look forward to an exciting second half of calendar 2016."

Third Quarter Highlights

Commenced enrollment in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) as a treatment to improve visual acuity for patients with wet AMD.
The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
Dr. Brown is Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston.
Completed an in vivo study demonstrating sustained pharmacological anti-angiogenic activity of OHR3031, an angiogenesis inhibitor
Single intravitreal injection of microparticles containing OHR3031 produced clinically meaningful and statistically significant efficacy six weeks after dose administration in a rabbit model of laser-induced CNV.
Dose response was observed in the reduction of average CNV lesion areas with OHR3031 compared to vehicle treatment, with the highest dose exhibiting a statistically significant effect at Week 6.
Magnitude of difference in average CNV lesion size for the high dose of OHR-3031 compared to vehicle treatment at 6 weeks was comparable to that seen at 2 weeks with a currently approved anti-VEGF agent conducted in a previous study.
OHR3031 was developed using SKS sustained release technology
Presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference in May.
Financial Results for Third Quarter ended June 30, 2016

For the third quarter ended June 30, 2016, the Company reported a net loss of approximately $7.7 million, or ($0.24) per share, compared to a net loss of approximately $3.3 million, or ($0.11) per share in the same period of 2015.
For the third quarter ended June 30, 2016, total operating expenses were approximately $7.6 million, consisting of approximately $1.7 million in general and administrative expenses, $5.6 million in research and development expenses, and $0.3 million in depreciation and amortization. This compares to total operating expenses in the same period of 2015 of approximately $3.3 million, consisting of $1.6 million in general and administrative expenses, $1.5 million in research and development expenses, and $0.3 million in depreciation and amortization.
At June 30, 2016, the Company had cash and cash equivalents of approximately $17.6 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
Financial Results for the Nine-Months ended March 31, 2016

For the nine months ended June 30, 2016, the Company reported a net loss of approximately $19.1 million, or ($0.61) per share, compared to a net loss of approximately $11.3 million, or ($0.41) per share in the same period of 2015.
For the nine months ended June 30, 2016, total operating expenses were approximately $17.8 million, consisting of $5.8 million in general and administrative expenses, $11.8 million of research and development expenses, and $0.9 million in depreciation and amortization. This compares to total operating expenses of $14.3 million in the same period of 2015, comprised of approximately $5.7 million in general and administrative expenses, $7.4 million in research and development expenses, and $0.9 million in depreciation and amortization.