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MAST THERAPEUTICS REPORTS SECOND QUARTER 2016 FINANCIAL RESULTS

On August 9, 2016 Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure, reported financial results for the quarter ended June 30, 2016.
"We continued to advance our assets toward valuable inflection points during the second quarter. Announcing top-line data from the EPIC study continues to be our top priority. With 388 subjects randomized at study sites around the globe, EPIC was the largest placebo-controlled study in sickle cell disease ever concluded and we look forward to announcing results next month. To support our NDA for vepoloxamer, we also continue to enroll patients in EPIC-E, our repeat exposure study for EPIC patients, and in a clinical pharmacokinetics study of vepoloxamer in individuals with varying degrees of renal insufficiency," stated Brian M. Culley, Chief Executive Officer.

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"In addition, clinical development of AIR001 in heart failure with preserved ejection fraction is progressing through multiple Phase 2 studies. In particular, we are pleased that the first patient was dosed in the 100-patient Phase 2 study being conducted by the Heart Failure Clinical Research Network," continued Mr. Culley.

Second Quarter 2016 Operating Results

The Company’s net loss for the second quarter of 2016 was $10.7 million, or $0.05 per share (basic and diluted), compared to a net loss of $10.2 million, or $0.06 per share (basic and diluted), for the same period in 2015.

Research and development (R&D) expenses for the second quarter of 2016 were $7.8 million, compared to $7.7 million for the same period in 2015. Increases of $0.5 million in external clinical study fees and expenses and $0.1 million in share-based compensation expense were offset by a $0.5 million decrease in external nonclinical study fees and expenses.

The increase in external clinical study fees and expenses was due primarily to increased costs related to the Company’s Phase 2 study of vepoloxamer in heart failure ($0.7 million) and the Phase 2 studies of AIR001 in HFpEF ($0.4 million), offset by decreases in costs for the EPIC study ($0.4 million) and the Phase 2 study of vepoloxamer in acute limb ischemia, which the Company began to wind-down in the third quarter of 2015 ($0.2 million). The decrease in external nonclinical study fees and expenses was due primarily to decreases in research-related manufacturing costs for vepoloxamer ($1.2 million) and nonclinical studies of vepoloxamer ($0.4 million), offset by increased costs related to preparing a new drug application for vepoloxamer ($0.9 million) and research-related manufacturing for AIR001 ($0.2 million).

Selling, general and administrative (SG&A) expenses were $2.4 million in each of the second quarter of 2016 and the second quarter of 2015.

Interest expense for the second quarter of 2016 was $512,000, $511,000 of which was related to the Company’s debt facility. There was interest expense of $1,000 for the second quarter of 2015.

Year-to-Date Financial Results

The Company’s net loss for the six months ended June 30, 2016 was $21.9 million, or $0.12 per share (basic and diluted), compared to a net loss of $19.8 million, or $0.12 per share (basic and diluted), for the same period in 2015.

R&D expenses for the six months ended June 30, 2016 were $15.6 million, an increase of $1.8 million, or 13%, compared to $13.8 million for the same period in 2015. The increase was due primarily to increases of $1.0 million in external clinical study fees and expenses, $0.4 million in external nonclinical study fees and expenses, $0.2 million in personnel expenses and $0.2 million in share-based compensation.

The $1.0 million increase in external clinical study fees and expenses was due primarily to increases in costs for our Phase 2 study of vepoloxamer in heart failure ($1.2 million) and the Phase 2 studies of AIR001 in HFpEF ($0.4 million), offset by a decrease in costs for the Phase 2 study of vepoloxamer in ALI ($0.5 million). The $0.4 million increase in external nonclinical study fees and expenses was due primarily to increases in costs related to preparing a new drug application for vepoloxamer ($1.4 million) and research-related manufacturing for AIR001 ($0.2 million), offset by decreases in research-related manufacturing costs for vepoloxamer ($0.8 million) and costs for nonclinical studies of vepoloxamer ($0.3 million).

SG&A expenses for the six months ended June 30, 2016 were $5.3 million, a decrease of $0.7 million, or 12%, compared to $6.0 million for the same period in 2015. SG&A expenses for the first six months of 2015 included $0.4 million of severance expenses and $0.3 million of share-based compensation resulting from the termination of employment of the Company’s former president and chief operating officer in February 2015 and the acceleration of stock option vesting pursuant to the terms of his option agreements.

Interest expense for the six months ended June 30, 2016 was $1,031,000, $1,029,000 of which was related to the Company’s debt facility. There was interest expense of $1,000 for the same period of 2015.

LabCorp Commences Cash Tender Offer for All Outstanding Shares of Sequenom, Inc.

On August 9, 2016 Laboratory Corporation of America Holdings (NYSE: LH) reported the commencement of its cash tender offer for all outstanding shares of the common stock of Sequenom, Inc. (NASDAQ: SQNM) for $2.40 per share (Press release, LabCorp, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194107 [SID:1234514422]). The tender offer is being made by Savoy Acquisition Corp., a wholly owned subsidiary of LabCorp, pursuant to an offer to purchase, dated August 9, 2016. LabCorp and Sequenom previously announced that they entered into an agreement and plan of merger, dated as of July 26, 2016, for LabCorp to acquire Sequenom.

The board of directors of Sequenom, Inc. has determined that the merger agreement, the offer and the merger are fair and advisable to, and in the best interests of Sequenom and its stockholders. The Sequenom board also agreed that the merger agreement shall be effected under Section 251(h) of the Delaware General Corporation Law, approved the merger agreement, the offer, the merger and the other transactions contemplated thereby, and recommended that Sequenom stockholders accept the offer and tender their shares in the offer.

The tender offer and any withdrawal rights are scheduled to expire at 12:01 a.m., New York City Time, on Wednesday, September 7, 2016, unless the tender offer is extended.

Following the successful completion of the tender offer, LabCorp expects to merge Savoy Acquisition Corp. into Sequenom without a vote of the stockholders of Sequenom, resulting in any shares not purchased in the tender offer being converted into the right to receive the same cash price per share as paid in the tender offer. The tender offer and the merger are subject to customary closing conditions set forth in the merger agreement, including the acquisition by Savoy Acquisition Corp. of a majority of Sequenom’s outstanding shares at the time of the consummation of the offer and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The closing of the acquisition is expected by year end.

The complete terms and conditions of the tender offer are set forth in the offer to purchase, letter of transmittal and other related materials filed with the Securities and Exchange Commission (SEC) on August 9, 2016 as exhibits to a tender offer statement on Schedule TO filed by LabCorp and Savoy Acquisition Corp. In addition, on August 9, 2016, Sequenom filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC related to the tender offer.

Important Additional Information Has Been Filed with the SEC

The tender offer described in this press release has commenced, but this press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Sequenom, Inc.’s common stock. The tender offer is being made pursuant to a tender offer statement and related materials (including the Offer to Purchase and the letter of transmittal). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND RELATED MATERIALS (INCLUDING THE OFFER TO PURCHASE AND LETTER OF TRANSMITTAL) AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION. The tender offer statement on Schedule TO and related materials, including the offer to purchase and letter of transmittal, have been filed by Laboratory Corporation of America Holdings and Savoy Acquisition Corp. with the SEC and mailed to Sequenom stockholders. The solicitation/recommendation statement on Schedule 14D-9 has been filed by Sequenom, Inc. with the SEC and mailed to Sequenom stockholders. Investors and security holders may obtain a copy of these statements at no cost and other documents filed by Laboratory Corporation of America Holdings and Savoy Acquisition Corp. or Sequenom, Inc. with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer statement and related materials, solicitation/recommendation statement, and such other documents may be obtained at no cost by directing such requests to Morrow Sodali Global, LLC, the information agent for the tender offer, at 1-203-658-9400 for banks and brokers or 1-800-662-5200 for shareholders and all others.

Immune Design Reports Second Quarter 2016 Financial Results and Provides Corporate Update

On August 9, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the second quarter ended June 30, 2016 (Press release, Immune Design, AUG 9, 2016, View Source [SID:1234514421]).

"The positive data we presented during the second quarter provide a strong rationale for the continued advancement of our two lead programs, CMB305 and G100," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "These two programs offer distinct approaches that use the patient’s immune system to fight cancer, and which are different from previous efforts in this field."

Recent Highlights

Product Development Progress

Specific Antigen Approach: LV305/CMB305 and ZVex-Neo Programs

LV305/CMB305: Positive data in NY-ESO-1 Soft Tissue Sarcoma (STS) patients, Phase 2 combination study in collaboration with Genentech ongoing.

LV305: Positive PFS and OS data in STS
Data from the single agent Phase 1 study in 24 patients with advanced or metastatic soft tissue sarcoma, which were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, revealed:
clinical benefit for 58% of the patients in the form of partial response (PR) or stable disease (SD);
median progression-free survival (PFS) of 4.6 months and a median overall survival (OS) that had not yet been reached, with 81% of the patients alive at one year; and
very favorable safety profile, with no Grade 3/4 adverse events (AEs)
We believe these data compare favorably with approved STS agents and further support the applicability of the mechanism of action of the Prime/Boost agent, CMB305, in STS, and as a potential first registration path for an Immune Design product.
CMB305: (1) positive STS signal in early look; and (2) randomized Phase 2 combination study with Genentech’s anti-PDL1 antibody, TECENTRIQ (atezolizumab) ongoing in STS

Early data from the single agent Phase 1 study in 14 patients with STS showed
the median OS had not been reached, with 93% of the patients alive at one year, and the median PFS was 5.5 months, both of which we believe compare favorably to approved chemotherapy agents for STS patients who have received at least one or more prior therapies;
a favorable safety profile, with only Grade 1/2 AEs; and
a deeper immune response than seen in the LV305 Phase 1 study, including a trend of increased T cell clonality.
A randomized 80-patient Phase 2 study of CMB305 with or without the anti-PD-L1 checkpoint inhibitor, atezolizumab, is ongoing in patients with STS
Part 1 of the study included a safety run in, which was deemed favorable by an independent Data Monitoring Committee, allowing enrollment in part 2 of the study to commence.
ZVex-Neo: Neoantigen Collaboration with Gritstone Oncology
In May 2016, Immune Design announced a collaboration with Gritstone Oncology to combine Immune Design’s ZVex discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies. The collaboration has commenced, with the intent to begin a study in patients with non-small cell lung cancer in 2017 in combination with a checkpoint inhibitor of the PD-1/PD-L1 axis.
Intratumoral Immune Activation Approach: Positive Clinical and Translational Data

G100: (1) positive final Phase 1 results in Merkel cell carcinoma (MCC); and (2) randomized Phase 2 combination with KEYTRUDA (pembrolizumab) in follicular non-Hodgkin’s lymphoma (NHL) in collaboration with Merck is ongoing
The final results of a 10-patient Phase 1 study of G100 administered intratumorally and combined with radiation in patients with MCC, which were presented at the ASCO (Free ASCO Whitepaper) annual meeting, revealed:
a 50% overall response rate (ORR) per protocol, including one of the complete responses (CR) resulting from single agent G100 alone (no radiation);
no treatment-related AEs were observed, and all AEs were grade 1/2; and
analysis of the tumor microenvironment (TME) in G100-responding patients demonstrated the increase of innate immune molecules that favor (i) immune cell chemotaxis, (ii) increased NK cells and M1 macrophage markers, and (iii) dendritic cell antigen presentation and dynamics of adaptive immunity such as trafficking of CD8 and CD4 T cells from the stroma into the tumor bed, underscoring the transition to a "hot" tumor.
A randomized Phase 2 study of G100 with low dose radiation, with Merck’s checkpoint inhibitor KEYTRUDA (pembrolizumab) in NHL patients is ongoing.
Part 1 (dose escalation of G100 without Keytruda) was deemed safe, allowing the move to Part 2 of the study, in which patients are randomized to receive Keytruda in combination with G100 and radiation or G100 and radiation alone.
Expansion of the Team

Susan L. Kelley M.D. Joins Board of Directors: Addition of Oncology Development Expertise

Dr. Susan L. Kelley joined the Immune Design Board in June 2016, and brings more than 25 years’ experience in oncology and immunology drug development to the company.
Financial Results

Second Quarter

Immune Design ended the second quarter of 2016 with $92.6 million in cash, cash equivalents and short-term investments, compared to $112.9 million as of December 31, 2015. Net cash used in operations for the six months ended June 30, 2016 was $20.4 million.
Net loss and net loss per share for the second quarter of 2016 were $14.3 million and $0.71, respectively, compared to $10.5 million and $0.54, respectively, for the second quarter of 2015.
Revenue for the second quarter of 2016 was $1.1 million and was attributable primarily to the Sanofi G103 (HSV2 therapeutic vaccine) collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners Medimmune/Astra Zeneca and Sanofi. Revenue for the second quarter of 2015 was $1.8 million and was attributable primarily to collaboration revenue associated with Sanofi G103 collaboration.
Research and development expenses for the second quarter of 2016 were $11.4 million, compared to $8.5 million for the second quarter of 2015. The $2.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses did not materially differ over the comparative periods. For the second quarter of 2016 general and administrative expenses were $3.9 million, compared to $3.8 million for the second quarter of 2015.
Year-to-Date

Net loss and net loss per share for the six months ended June 30, 2016 were $26.6 million and $1.32, respectively, compared to $19.9 million and $1.10, respectively, for the same period in 2015.
Revenue for the six months ended June 30, 2016 was $3.0 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners. Revenue for the same period in 2015 was $3.7 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the six months ended June 30, 2016 were $22.0 million compared to $15.9 million for the same period in 2015. The $6.0 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.
General and administrative expenses did not materially differ over the comparative periods. For the six months ended June 30, 2016 general and administrative expenses were $7.9 million, compared to $7.6 million for the same period in 2015.

Genmab Announces Financial Results for the First Half of 2016 and Improves 2016 Financial Guidance

On August 9, 2016 Genmab reported its Interim Report for First Half 2016 (Press release, Genmab, AUG 9, 2016, View Source [SID:1234514420]).

Net Sales of DARZALEX (daratumumab) by Janssen for the first half of 2016 were USD 209 million, resulting in royalty income of USD 25 million (DKK 168 million)
2016 financial guidance improved
Announced European conditional marketing authorization of DARZALEX for heavily pre-treated or double-refractory multiple myeloma
Achieved USD 30 million milestone for first commercial sale of DARZALEX in Europe
Announced positive topline result in Phase III POLLUX study of daratumumab in relapsed or refractory multiple myeloma
Announced that U.S. Food and Drug Administration (FDA) granted priority review to sBLA for ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) in relapsed chronic lymphocytic leukemia (CLL)
Announced that the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Arzerra as maintenance therapy in relapsed CLL
Announced Phase III studies of ofatumumab in relapsing multiple sclerosis
"The two major highlights during the second quarter were the rapid European approval of DARZALEX and positive Phase III data from the POLLUX study. DARZALEX was successfully launched by our collaboration partner Janssen shortly after the approval, triggering a milestone payment of USD 30 million to Genmab. We were also very excited about the Phase III POLLUX study data which showed that daratumumab in combination with lenalidomide and dexamethasone led to a significant improvement in progression free survival in treatment of relapsed or refractory multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
Revenue was DKK 524 million in the first half of 2016 compared to DKK 281 million in the first half of 2015. The increase of DKK 243 million, or 86%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
Operating expenses were DKK 366 million in the first half of 2016 compared to DKK 244 million in the first half of 2015. The increase of DKK 122 million, or 50%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
Operating income was DKK 158 million in the first half of 2016 compared to DKK 212 million in the first half of 2015. The decrease of DKK 54 million, or 25%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015 combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
On June 30, 2016, Genmab had a cash position of DKK 3,762 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 269 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants for DKK 82 million.
Business Progress Second Quarter

Daratumumab
May: Achieved a USD 30 million milestone triggered by the first commercial sale of DARZALEX in Europe.
May: Announced that the European Commission (EC) granted a conditional marketing authorization for DARZALEX for heavily pre-treated or double-refractory multiple myeloma. The approval followed a positive recommendation for DARZALEX from the CHMP of the European Medicines Agency (EMA) in April.

May: Announced that the Phase III POLLUX study (MMY3003) of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma met the primary endpoint at a pre-planned interim analysis (Hazard Ratio (HR) = 0.37 (95% CI 0.27-0.52), p<0.0001). Patients who received treatment with daratumumab in combination with lenalidomide and dexamethasone had a 63% reduction in risk of their disease progressing, compared to those who did not receive daratumumab. The median progression free survival (PFS) for patients treated with daratumumab in combination with lenalidomide and dexamethasone has not been reached, compared to an estimated median PFS of 18.4 months for patients who received lenalidomide and dexamethasone alone. Janssen will engage in a dialogue with health authorities about the potential for a regulatory submission for this indication.

April: Reported more detailed data from the Phase III CASTOR (MMY3004) study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met the primary endpoint of improving PFS; HR = 0.39, p<0.0001. The median PFS for patients treated with daratumumab has not been reached, compared to median PFS of 7.2 months for patients who did not receive daratumumab.

April: Announced that MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Janssen Biotech, Inc. (Janssen), for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the manufacture, use and sale of DARZALEX in the United States. Genmab and Janssen disagree with the allegations made by MorphoSys in its complaint for patent infringement and intend to vigorously contest those allegations.

Ofatumumab
June: Announced that the CHMP of the EMA issued a negative opinion on the use of Arzerra as maintenance therapy for patients with relapsed CLL.

June: Announced that Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrollment of patients to start in September 2016.

May: Announced that the U.S. FDA granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of ofatumumab in combination with FC for the treatment of patients with relapsed CLL.

Subsequent Event
July: The U.S. FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy.

Calithera Biosciences Reports Second Quarter 2016 Financial Results and Recent Highlights

On August 9, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor and tumor immune cell metabolism targets for the treatment of cancer, reported its financial results for the second quarter ended June 30, 2016. As of June 30, 2016, cash, cash equivalents and investments totaled $60.4 million (Press release, Calithera Biosciences, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194344 [SID:1234514418]).

"During the second quarter, we significantly advanced our pipeline of novel cancer therapeutics," said Susan Molineaux, Ph.D., President and Chief Executive Officer of Calithera. "Data presented on the tumor metabolism drug CB-839 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) helped us to define a path forward for clinical development in renal cell carcinoma and triple negative breast cancer. With the FDA’s acceptance of our IND for our metabolic immune checkpoint drug candidate CB-1158, we now have two novel metabolic agents targeting tumor and immune cell metabolism in clinical development."

Second Quarter 2016 and Recent Highlights

FDA acceptance of Investigational New Drug Application for CB-1158. In July 2016, the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application for CB-1158 for the treatment of solid tumors. CB-1158 is a first-in-class immuno-oncology metabolic checkpoint inhibitor targeting arginase, an immunosuppressive enzyme in myeloid-derived suppressor cells responsible for T-cell suppression. Arginase exerts its immunosuppressive effect by depleting the amino acid arginine in the tumor microenvironment and preventing activation and proliferation of the immune system’s cytotoxic T-cells and natural killer (NK) cells. Inhibition of arginase activity reverses this immunosuppressive block and restores T-cell function. The Phase I clinical trial will enroll patients with advanced solid tumors treated with CB-1158 as a monotherapy, as well as in combination with an anti-PD1 antibody.
CB-839 solid tumor combination data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). In June 2016, Calithera presented clinical data for CB-839 in combination with everolimus in renal cell carcinoma, and CB-839 in combination with paclitaxel in triple negative breast cancer. Among ten renal cell carcinoma patients treated in the everolimus combination group, the overall disease control rate was 80%, including one partial response. Among eight clear cell and papillary patients, the disease control rate was 100%. The median time on study exceeded the expected progression free survival for everolimus alone in this population. Fifteen triple negative breast cancer patients were treated with CB-839 in combination with paclitaxel. The majority of patients had received at least three prior lines of therapy. Most patients had received prior taxanes in either the neo-adjuvant, adjuvant or metastatic setting. Among patients treated with CB-839 doses of at least 600 mg bid (n=8), there were 3 partial responses (38%) and disease control (response or stable disease) in 7 patients (88%). Two of the partial responses were observed in patients refractory to paclitaxel in a prior course of therapy. CB-839 in combination with either everolimus or paclitaxel has been well tolerated to date, with adverse events that have been manageable and reversible.
Selected Second Quarter 2016 Financial Results

Research and development expenses were $7.8 million for the three months ended June 30, 2016, compared with $5.5 million for the same period in the prior year. The increase of $2.2 million was primarily attributed to increased development activities in Calithera’s arginase inhibitors program.

General and administrative expenses were $2.7 million for the three months ended June 30, 2016, compared with $2.3 million for the same period in the prior year. The increase of $0.3 million was primarily due to higher employment related expenses, including stock-based compensation expense.

Net loss for the three months ended June 30, 2016 was $10.4 million, or $0.55 per share.