On August 11, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal fourth-quarter and fiscal full year ended June 30, 2015, provided an update on recent business highlights and provided fiscal year 2016 and fiscal first-quarter 2016 financial guidance (Press release, Myriad Genetics, AUG 11, 2015, View Source [SID:1234507203]).

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"We delivered sequential growth in the fourth quarter and made significant progress towards completing the conversion of our targeted physician base to myRisk Hereditary Cancer testing," said Mark C. Capone, president and chief executive officer of Myriad. "As we look forward to fiscal year 2016, we are confident that we are poised to generate top- and bottom-line growth beginning a trend that reflects increased investments in our product pipeline and international expansion. Over the next several years, we expect that these investments will drive revenue growth and operating leverage as we look to transform Myriad into a worldwide personalized medicine company."

Financial Highlights

myRisk Hereditary Cancer testing revenue increased to $100.9 million in the fourth quarter of fiscal 2015 from $27.3 million in the fourth quarter of the prior year, and the Company exited the quarter with 72 percent of incoming hereditary cancer samples ordered as myRisk.

The decline in both adjusted operating and net income in the fiscal fourth quarter 2015 relative to the prior year is attributable to lower gross margins associated with the transition costs of myRisk Hereditary Cancer testing and incremental product launch expenses for Prolaris, myPath Melanoma and myPlan Lung Cancer tests.

During the quarter, the Company repurchased approximately 1.3 million shares, or $45 million, of common stock under its share repurchase program and ended the quarter with approximately $155 million remaining on its current share repurchase authorization. Fiscal fourth-quarter diluted weighted average shares outstanding were 72.4 million compared to 77.7 million in the same period last year.

Business Highlights

Myriad presented data on 19 abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) including:
Results from the Geparsixto study that showed the ability of the myChoice HRD test to predict response to carboplatin containing chemotherapy in 193 patients with triple negative breast cancer. The highest response rate of 64 percent was seen in patients with a positive HRD score who received both carboplatin and standard of care chemotherapy, compared to 30 percent in patients with a negative HRD score.

Data demonstrating the ability of myChoice HRD to identify responders to Tesaro’s novel therapeutic drug candidate niraparib. In a study of 106 patients with advanced ovarian cancer, myChoice HRD identified 100 percent of responders to the investigational drug.

A study of almost 77,000 patients tested with myRisk Hereditary Cancer demonstrated that the detection rate for mutations increased 130 percent relative to BRCA1/BRCA2 testing alone. We also presented a study on endometrial cancer demonstrating that over 9 percent of patients carried a deleterious mutation in one of the myRisk genes, which we believe justifies broad testing for this population consistent with recent National Comprehensive Cancer Network (NCCN) recommendations.
Vectra DA volumes increased to a new record in the fiscal fourth quarter, growing 12 percent sequentially to just under 40,000 tests ordered with revenue up 12 percent sequentially to $11.8 million.

Presented data at the America Urological Association (AUA) meeting including:
Key data defining an active surveillance threshold for our Prolaris test. The active surveillance threshold sets a defined cutoff for patients and has been clinically validated to show patients with scores below the cutoff have a 10-year prostate cancer specific mortality of less than 3 percent.

The final results of the PROCEDE 1,000 clinical utility study that evaluated the impact of the Prolaris score on treatment recommendations for 1,206 prostate cancer patients. The final data showed that physicians had a 48 percent change in treatment recommendations in which 35 percent of patients saw a reduction in therapy and 13 percent saw an increase in therapy.

Fiscal First-Quarter and Fiscal Full Year 2016 Financial Guidance

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call it is holding today to discuss its fiscal fourth quarter and full year 2015 financial results and fiscal year 2016 financial guidance.

On August 11, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the second quarter ended June 30, 2015 (Press release, Cyclacel, AUG 11, 2015, View Source [SID:1234507201]).

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The Company’s net loss applicable to common shareholders for the second quarter ended June 30, 2015 was $3.4 million, or $0.10 per basic and diluted share, compared to a net loss income applicable to common shareholders of $4.9 million, or $0.22 per basic and diluted share for the second quarter ended June 30, 2014. As of June 30, 2015, cash and cash equivalents totaled $26.9 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 13% of events remaining to occur and we expect to report top-line data during the second half of 2015 through the first half of 2016. Following unblinding and analysis of the SEAMLESS data, we will determine their suitability for submission to regulators in the U.S. and Europe. Additionally, in the Phase 1 study of our all-oral combination of sapacitabine with our first-generation CDK2/9 inhibitor, seliciclib, we reported updated data in heavily pretreated cancer patients with BRCA mutations. The data showed a 55% overall response rate with patients achieving durable benefit after multiple cycles of therapy, including a breast cancer patient who has received to date over 60 cycles. These promising data are encouraging us to explore this regimen further. Our next generation CDK2/9 inhibitor, CYC065, received institutional review board approval for a first-in-human, Phase 1 study in advanced solid tumors and we expect to start treating patients shortly. CYC065 has demonstrated increased potency compared to seliciclib. Based on published preclinical efficacy data, we plan to develop CYC065 as a targeted anticancer agent in both hematological and solid cancers. In addition to our focus on SEAMLESS, we have continued to make progress with our other programs, while ensuring we have sufficient resources to deliver on our key milestones and execute on our business strategy."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

Continued to follow-up patients as 13% of events remain to occur before analyzing the data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.
Sapacitabine and seliciclib, all-oral combination in Phase 1 study in patients with advanced solid tumors

Observed an overall response rate of 55% in breast, ovarian and pancreatic patients with BRCA mutations in updated data from this study of heavily pre-treated patients.

Cyclin Dependent Kinase (CDK) Inhibitor Programs

Received institutional review board approval to start a first-in-human Phase 1 trial of CYC065, the Company’s second generation CDK2/9 inhibitor, in solid tumor patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065.
Presented preclinical data demonstrating therapeutic potential of CYC065 as a targeted anticancer agent at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2015. The data show that CYC065 may reverse drug resistance associated with addiction of cancer cells to cyclin E, the partner protein of CDK2. CYC065 may also inhibit CDK9-dependent oncogenic and leukemogenic pathways, including malignancies driven by certain oncogene and MLL rearrangements. MLL gene status and levels of Bcl-2 family proteins correlated with sensitivity of AML cell lines to CYC065. CYC065’s anticancer activity presents an opportunity for patient stratification and combinations with anti-leukemic agents. CYC065 was also effective against uterine cancer cells including those resistant to chemotherapy and was especially potent in uterine cancer cells in which cyclin E was amplified or overexpressed.
Entered into a license and supply agreement with ManRos Therapeutics regarding the development of seliciclib, the Company’s first generation CDK inhibitor, in cystic fibrosis.

Dosed first patient in Phase 2 investigator sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

Other Events

Entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co., as sales agent ("Cantor"), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor.

Transferred the listing of the Company’s common stock from the NASDAQ Global Market to the NASDAQ Capital Market effective at the opening of business on August 6, 2015. The Company’s common stock will continue to trade under the symbol "CYCC." The Company currently meets the NASDAQ Capital Market initial listing criteria, except for the bid price requirement. With the transfer to the NASDAQ Capital Market, the Company is being afforded an additional 180-day grace period to regain compliance with NASDAQ’s minimum bid price requirement of a stock price of at least $1.00 for at least ten consecutive business days during this grace period ending on February 2, 2016 or be delisted.

Second Quarter 2015 Financial Results

Grant Revenue

Revenue for the three months ended June 30, 2015, was $0.3 million compared to $0.4 million for the same period of the previous year. The revenue is related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government.

Research and Development Expenses

Research and development expenses were $2.6 million for the three months ended June 30, 2015, compared to $4.5 million for the same period in the previous year. The decrease was primarily a result of reduced expenditure in the SEAMLESS Phase 3 study this quarter compared to the same period last year.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2015 remained relatively flat at $1.3 million compared to $1.4 million for the same period in 2014.

On August 11, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, reported business highlights and financial results for the second quarter ended June 30, 2015 (Press release, Celator Pharmaceuticals, AUG 11, 2015, View Source [SID:1234507200]).

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"We capped off a very busy second quarter by reporting positive induction response rate data in the Phase 3 study of VYXEOS (CPX-351) in patients with high-risk (e.g. secondary) acute myeloid leukemia (AML)," said Scott Jackson, chief executive officer of the Company. "We believe response is an important surrogate for overall survival and clinical benefit in this patient population. We intend to build on that momentum as we advance our broader clinical development program, report data on CombiPlex technology platform studies, and increase pre-commercial activities." Mr. Jackson continued, "Data on overall survival are expected in the first quarter of 2016, with an NDA submission planned for the third quarter of 2016. If approved, VYXEOS will be well-positioned to become the foundation of care for high-risk AML patients."

Second Quarter 2015 and Recent Highlights:

The Company reported positive induction response rate results from the Phase 3 study of CPX-351 in patients with high-risk (e.g. secondary) AML.

The FDA granted approval of the brand name VYXEOS for CPX-351.

Enrollment was completed in a Phase 2 pharmacokinetic and pharmacodynamics (PK/PD) study evaluating the effects of CPX-351 on cardiac repolarization in adult patients with acute hematologic malignancies, including AML, acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS).

As part of the Company’s existing $5 million Phase 3 partnership with the Leukemia & Lymphoma Society, Celator achieved a milestone payment of $900,000 based on positive induction response rate data from the Phase 3 study, thereby bringing the total amount received to date to $4.9 million.

At the Company’s Analyst and Investor Day, management presented an overview of the company’s growth strategy which included VYXEOS and our proprietary technology platform, CombiPlex. Key thought leaders, Gail Roboz, M.D. and Bruno C. Medeiros, M.D., discussed AML and VYXEOS. In addition, Anthony Tolcher, M.D., presented on the challenges and opportunities of combining molecularly targeted agents which may be addressed by CombiPlex. The presentations are on the Company’s website at: View Source!events-and-presentations/c1iw5

The Company announced that enrollment had commenced in an investigator-initiated Phase 2 clinical study, at MD Anderson Cancer Center, evaluating CPX-351 as a treatment for patients with newly diagnosed AML at high risk for induction treatment mortality.

Based on encouraging safety and efficacy results, a patient cohort was expanded in an investigator-initiated study, being conducted at both the Fred Hutchinson Cancer Research Center and Stanford University, evaluating CPX-351 in patients with either untreated MDS or AML at high-risk of treatment-related mortality.

Data were presented describing the effects of combining CPX-351 with traditional chemotherapy and novel molecularly targeted agents intended for use in treating AML and other blood cancers at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Financial Highlights:

Cash Position: Cash and cash equivalents as of June 30, 2015 were $28.5 million, compared to $32.4 million as of December 31, 2014. The decrease of $3.9 million was primarily due to $9.0 million of net cash used in operating activities, partially offset by $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. Cash and cash equivalents as of March 31, 2015 were $32.9 million. Management believes that the cash and cash equivalents at June 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.

R&D Expenses: Research and development expenses were $3.5 million and $6.2 million for the three and six months ended June 30, 2015, as compared to $2.9 million and $5.9 million for the same periods in 2014. The increase in R&D expenses in the comparable three-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and additional manufacturing costs. The increase between the comparable six-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and were partially offset by reduced manufacturing and research costs.

G&A Expenses: General and administrative expenses were $2.0 million and $3.8 million for the three and six months ended June 30, 2015, as compared to $1.7 million and $3.6 million for the same periods of 2014. The increases were primarily attributable to increases in investor relations, professional fees and public company-related costs. These increases were offset by decreases in consulting costs associated with commercial development.

Net Loss: Net loss was $5.0 and $9.7 million for the three and six months ended June 30, 2015, as compared to $4.8 million and $9.1 million for the same periods in 2014.

On August 11, 2015 Genmab reported Financial Results for the First Half of 2015 (Press release, Genmab, AUG 11, 2015, View Source [SID:1234507199]).

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Interim Report First Half 2015

Rolling submission of BLA to U.S. FDA for daratumumab in double refractory multiple myeloma completed by Janssen, triggering a USD 15 million milestone payment

Regulatory submissions for ofatumumab (Arzerra) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA

Achieved USD 10 million milestone payment under daratumumab collaboration with Janssen for progress in Phase III study ("Alcyone" MMY3007)

Positive top-line results from the Phase III COMPLEMENT 2 study of ofatumumab plus fludarabine and cyclophosphamide in relapsed CLL

Entered commercial agreement for DuoBody platform with BioNTech in the field of immuno-oncology

Improved operating result by DKK 147 million over the first half of 2014

"During the second quarter we continued to see steady advances in our two most advanced programs, daratumumab and ofatumumab. The daratumumab program continues to progress very rapidly with the first regulatory application submitted in the U.S. by Janssen Biotech, Inc. under our collaboration. Together with Novartis, we reported positive top-line results in a pivotal study of ofatumumab in combination with fludarabine and cyclophosphamide in relapsed CLL; the data will be shared with the regulatory authorities to determine the potential for regulatory filings. Regulatory submissions for ofatumumab as maintenance therapy in relapsed CLL were submitted by Novartis to the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in July. We also continue to focus on our technologies and effectively progress a robust early stage pipeline, having entered an agreement with BioNTech for the DuoBody platform in the field of immuno-oncology and obtaining a license from Bristol-Myers Squibb for antibodies targeting CD19," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half
Revenue was DKK 281 million in the first half of 2015 compared to DKK 363 million in the first half of 2014. The decrease of DKK 82 million or 23% was mainly driven by lower milestone revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 244 million in the first half of 2015 compared to DKK 298 million in the first half of 2014. The decrease of DKK 54 million or 18% was primarily related to a decrease in costs associated with the ofatumumab and daratumumab programs, which was partly offset by increased investment in our research and technology platforms.

Operating income was DKK 212 million in the first half of 2015 compared to DKK 65 million in the first half of 2014. The improvement of DKK 147 million was driven by the income from reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.

On June 30, 2015, Genmab had a cash position of DKK 2,958 million. This represented a net increase of DKK 297 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 478 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.

Business Progress Second Quarter to Present
July: The rolling submission of a Biologics License Application (BLA) to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab. The initiation of the rolling submission was announced in June. (Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab in 2012.)

July: Announced that regulatory applications were submitted to the EMA and FDA for the use of ofatumumab as maintenance therapy of patients with relapsed CLL by Novartis.

June: Entered an agreement for an exclusive license from Bristol-Myers Squibb to a panel of human antibodies targeting CD19.
May: Entered an agreement with BioNTech AG to jointly research, develop and commercialize bispecific antibody products within the field of immuno-oncology using the DuoBody technology platform.

May: Presented first preliminary clinical data from the ongoing Phase I study of HuMax-TF-ADC in solid tumors, showing that HuMax-TF-ADC can be dosed safely in therapeutically meaningful doses and with encouraging early signs of efficacy.

April: Announced positive top-line results from the Phase III COMPLEMENT 2 study which showed that treatment with Arzerra plus fludarabine and cyclophosphamide met the primary endpoint of improved progression-free survival (PFS) in patients with relapsed CLL (HR 0.67, p = 0.0032) compared to those given fludarabine and cyclophosphamide alone. The data will be shared with the US and EU regulatory agencies to evaluate the potential for future regulatory filings.

April: Achieved a USD 10 million milestone payment in the daratumumab collaboration with Janssen for progress in the ongoing Phase III study ("Alcyone" MMY3007) which compares daratumumab in combination with bortezomib, melphalan and prednisone (VMP) to VMP alone as front line treatment for multiple myeloma patients who are not considered candidates for stem cell transplantation.

Outlook
Genmab is maintaining its updated 2015 financial guidance published on May 20, 2015.

On August 11, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three- and six-month periods ended June 30, 2015 (Press release, Eagle Pharmaceuticals, AUG 11, 2015, View Source [SID:1234507167]). Highlights of and subsequent to the second quarter of 2015 include:

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The U.S. Food and Drug Administration ("FDA") accepted for filing the New Drug Application ("NDA") for Eagle’s bendamustine hydrochloride (HCl) rapid infusion product (the "rapid infusion" product) for the treatment of patients with chronic lymphocytic leukemia ("CLL") and patients with indolent B-cell non-Hodgkin lymphoma ("NHL") that has progressed during or within six months of treatment with rituximab or a rituximab-containing regime. The FDA action date for this NDA under the Prescription Drug User Fee Act ("PDUFA") is December 13, 2015;

The FDA accepted for filing the NDA for Eagle’s unique, ready-to-use, liquid bivalirudin ("RTU bivalirudin") for the treatment of patients: (1) undergoing percutaneous coronary intervention ("PCI") with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty ("PTCA"). The FDA action date for this NDA under PDUFA is March 19, 2016;
The U.S. Patent and Trademark Office granted two new patents pertaining to the rapid infusion bendamustine product, both extending to March 2033;

RYANODEX (dantrolene sodium) for Injectable Suspension was granted seven years of U.S. market exclusivity for the treatment of malignant hyperthermia ("MH") by the FDA;

Advanced plans to conduct a clinical trial of RYANODEX for the treatment of exertional heat stroke, a potential new indication, in September 2015 in Saudi Arabia;

Product sales increased to $3.7 million compared to $0.4 million for the second quarter of 2014;

Total revenue was $6.0 million compared to $5.8 million for the second quarter of 2014;

Net loss was $(8.2) million, or $(0.53) per basic and diluted share, compared to a net loss attributable to common stockholders of $(2.9) million, or $(0.21) per basic and diluted share, for the second quarter of 2014; and

Cash, cash equivalents and short-term investments were $103.7 million at June 30, 2015.

"This was another very positive quarter for Eagle, marked by 22% sequential growth in product revenues and continued execution of our strategy. We now have NDAs for three significant products on file with the FDA, with PDUFA dates in the next eight months," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. "We expect that by this time next year, we will be marketing at least four products, which we estimate represents an aggregate market opportunity in excess of $1.4 billion, while also receiving royalties from Teva on sales of rapid infusion bendamustine, assuming regulatory approvals. We are very excited about Eagle’s growth prospects and our ability to deliver value to our shareholders."

Second Quarter 2015 Financial Results

Total revenue for the three months ended June 30, 2015 was $6.0 million, as compared to $5.8 million for the three months ended June 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 $3.3 million increase in product sales in the second quarter of 2015 was driven by $1.4 million in net sales of RYANODEX, $0.6 million in net sales of diclofenac/misoprostol, and a $1.3 million increase in argatroban sales.

The $0.3 million increase in royalty income in the second quarter of 2015 reflects higher end-use sales of argatroban by our commercial partners.

License and other income in the second quarter of 2014 was related to a milestone event associated with the FDA approval of diclofenac/misoprostol. There was no license and other income in the second quarter of 2015.

Cost of revenues increased by $1.8 million to $3.3 million in the second quarter of 2015 as compared to $1.5 million in the three months ended June 30, 2014, driven by higher sales of the three aforementioned products.

Research and development expenses were $5.9 million in the second quarter of 2015 as compared to $4.5 million in the three months ended June 30, 2014. The increase reflects an increase in spending due to the timing of the bivalirudin NDA submission, costs related to the pemetrexed program, and higher salaries and other personnel related expenses, offset in part by a decrease in spending related to bendamustine, for which the NDA was submitted in the first quarter of 2015, and diclofenac/misoprostol, which was launched in January.

Selling, general and administrative ("SG&A") expenses were $5.1 million in the second quarter of 2015 as compared to $2.7 million in the three months ended June 30, 2014. Sales and marketing expenses increased by $1.0 million to $1.9 million in the second quarter of 2015, primarily driven by RYANODEX marketing expenses. Other SG&A expenses increased by $1.2 million for salary and personnel-related expenses and $0.2 million related to professional fees, as compared with the prior year quarter.

Net loss for the second quarter of 2015 was $(8.2) million, or $(0.53) per basic and diluted share, compared to a net loss of $(2.9) million, or ($0.21) per basic and diluted share, for the three months ended June 30, 2014.

Liquidity

The Company had $103.7 million in cash, cash equivalents, and short-term investments; $194.6 million in additional paid in capital; and $96.4 million in stockholders’ equity as of June 30, 2015.