On August 5, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported financial results for the three and six months ended June 30, 2015 (Press release, Delcath Systems, AUG 5, 2015, View Source;p=RssLanding&cat=news&id=2075948 [SID:1234507026]).

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Highlights of the second quarter and recent weeks included:

Quarterly product revenue of $0.5 million, an increase of nearly 85.7% compared with the second quarter of 2014

Total operating expenses decreased by 35.1% to $4.0 million from $6.1 million in the second quarter of 2014

Enrollment opened for an intrahepatic cholangiocarcinoma (ICC) cohort of the Company’s global Phase 2 trial of Melphalan/HDS in hepatocellular carcinoma

Positive data regarding the Delcath Hepatic CHEMOSAT Delivery System highlighted at ASCO (Free ASCO Whitepaper) 2015

Exceeded 200 commercial treatments performed with CHEMOSAT since the product was launched in Europe

Multiple abstracts accepted for presentation at upcoming major medical conferences, including CIRSE, ESMO (Free ESMO Whitepaper), and EADO
Benefits of CHEMOSAT therapy to liver cancer patients affirmed by Key Opinion Leaders at European forum
Jennifer Simpson, Ph.D., MSN, CRNP named President and CEO

Granted U.S. Orphan Drug Designation for Melphalan/HDS for the treatment of cholangiocarcinoma from the U.S. Food and Drug Administration (FDA)

"We made considerable progress toward achieving our key milestones for 2015 as evidenced by continued revenue growth, increasing procedure volumes and advancement of our clinical development program," said Dr. Simpson. "We once again achieved record quarterly product revenue with year-over-year and sequential increases that have us already meeting our full-year 2014 sales on a local currency basis. This growth underscores our commercial progress in key European markets and highlights continued market adoption of CHEMOSAT.

"The opening of enrollment of the ICC cohort of our Phase 2 HCC study was a meaningful milestone as we believe our Melphalan/HDS treatment may offer significant clinical benefit for ICC patients who face limited treatment options. A positive efficacy signal may provide a regulatory path to a U.S. registration trial in this indication, and consolidated safety data from the HCC and ICC cohorts will offer valuable information for us to provide to the FDA. Our recent receipt of orphan drug designation from the FDA for melphalan for the treatment of cholangiocarcinoma, which includes ICC, highlights the medical need for viable treatments in this indication.

"We continue to advance our plans for a global pivotal Phase 3 clinical trial in ocular melanoma (OM) that has metastasized to the liver with overall survival as the primary endpoint. We hope to initiate this trial by the end of 2015.

"The positive feedback from the three-day Key Opinion Leader Forum we convened with leading clinicians from across Europe who are using CHEMOSAT was very encouraging. We look forward to these favorable findings being published in a white paper in a peer-reviewed journal.

"We are pleased with the meaningful progress made this quarter. With the additional resources secured through our recent public offering, we are well positioned to achieve several critical milestones during the second half of 2015," concluded Dr. Simpson.

Second Quarter Financial Results

Total revenue for the second quarter of 2015 of $0.5 million increased 85.7% from $0.3 million for the second quarter of 2014. Selling, general and administrative expenses during the second quarter of 2015 were $2.5 million, a decrease of $2.1 million or 45.6% from $4.6 million for the same period in 2014.

Total operating expenses for the second quarter of 2015 decreased by 35.1% to $4.0 million from $6.1 million for the same period in 2014. This decrease reflects a reduction in severance and compensation-related expenses following significant workforce restructurings throughout 2014 and into 2015, as well as a reduction in facility expenses following sub-leases of its 810 Seventh Ave location in 2014.

The Company recorded a net loss for the second quarter of 2015 of $3.7 million, a decrease of $0.9 million or 19.6%, compared with a net loss of $4.6 million for the same period in 2014. This decrease is primarily due to a $2.1 million reduction in operating expenses, a $0.1 million improvement in gross profit and a $1.3 million change in the fair value of the warrant liability, a non-cash item.

First Half Financial Result

Total revenue for the first half of 2015 of $0.9 million increased 62.2% from $0.6 million for the first half of 2014. Selling, general and administrative expenses during the first half of 2015 were $5.5 million, a decrease of $2.9 million or 34.1% from $8.4 million for the same period in 2014.

Total operating expenses for the first half of 2015 decreased by 29.9% to $8.0 million from $11.4 million for the same period in 2014. This decrease reflects a reduction in severance and compensation-related expenses following significant workforce restructurings throughout 2014 and into 2015, as well as a reduction in facility expenses following sub-leases of its 810 Seventh Ave location in 2014.

The Company recorded a net loss for the first half of 2015 of $7.2 million, a decrease of $2.7 million or 27.2% compared with a net loss of $9.9 million for the same period in 2014. This decrease is primarily due to a $3.4 million reduction in operating expenses, a $0.2 million improvement in gross profit and a $0.9 million change in the fair value of the warrant liability, a non-cash item.

Balance Sheet Highlights

Cash and cash equivalents as of June 30, 2015 were $14.1 million, compared with $20.5 million as of December 31, 2014. During the first six months of 2015, net cash used in operating activities was $9.0 million.

On August 5, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported two research projects involving the company’s Lm Technology immunotherapy candidate ADXS-PSA, which is being developed for prostate cancer, have been selected as 2015 Movember Foundation-PCF Challenge Awards, sponsored by the Movember Foundation and the Prostate Cancer Foundation (PCF) (Press release, Advaxis, AUG 5, 2015, View Source [SID:1234507025]). Grants amounting to $1 million each have been awarded to two ADXS-PSA teams conducting innovative large-scale research projects concerning metastatic, treatment-resistant prostate cancer, an advanced form of the disease with often-lethal outcomes.

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The Movember Foundation-PCF Challenge Awards support cross-disciplinary teams of investigators conducting pioneering research to address critical, unmet medical needs for prostate cancer patients. These highly competitive awards make large investments in multi-year projects that may fall outside the parameters of traditional funding organizations. Each proposal submitted to PCF was subjected to a rigorous peer review process that assessed the scientific merit of the project as well as its potential impact for patients. To date, the Movember Foundation has donated approximately $39 million to PCF to support innovative prostate cancer research, funding 28 research awards in the U.S., Canada and Great Britain.

Both ADXS-PSA projects awarded involve principal investigator Adam P. Dicker, M.D., Ph.D., Chair of the Department of Radiation Oncology at the Sidney Kimmel Cancer Center at Thomas Jefferson University, and will evaluate progression-free survival (PFS) as the primary endpoint and look at deep sequencing of T cell receptors to follow expansion of specific T cell clones.

"I look forward to having the opportunity to explore the potential of ADXS-PSA as immunotherapy in locally advanced and metastatic prostate cancer in two clinical trials," said Dr. Dicker. "These trials will help further the scientific understanding on the effects of targeting the prostate-specific antigen associated with prostate cancer."

The following ADXS-PSA proposals were selected to receive funding:

The first proposal, "CARAVAN (Checkpoint-Radiation-Vaccine Neoadjuvant) trial for metastatic prostate cancer," is led by researchers at the Sidney Kimmel Cancer Center at Thomas Jefferson University (Adam P. Dicker, M.D., Ph.D.) and the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center (Lawrence Fong, M.D.). This is a Phase 1/2 study investigating intraprostatic anti-CTLA-4 and PD-1 blockade, plus radiation and ADXS-PSA in metastatic prostate cancer (N= ~42 +/-, its variable).

The second proposal, "Altering the natural history of metastatic prostate cancer using stereotactic ablative radiotherapy and immune stimulation," is led by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (Phuoc T. Tran, M.D., Ph.D. and Ashley Ross, M.D., Ph.D.) and Sidney Kimmel Cancer Center at Thomas Jefferson University (Adam P. Dicker, M.D., Ph.D.). This is a Phase 1/2 study that combines stereotactic ablative radiation to prostate cancer metastases, followed by treatment with ADXS-PSA (N= ~36).

"We are tremendously honored to have ADXS-PSA recognized and supported in this way by the 2015 Movember Foundation-PCF Challenge Awards," said David J. Mauro, M.D., Ph.D., Executive Vice President and Chief Medical Officer of Advaxis. "This funding will bring about the research necessary to potentially bring ADXS-PSA immunotherapy to people with metastatic prostate cancer, a disease that is expected to take the lives of 27,540 men in 2015."

Advaxis recently announced that enrollment has initiated in the Phase 1/2 KEYNOTE-046 clinical trial evaluating the combination of ADXS-PSA and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). KEYNOTE-046 is the first-in-human study of ADXS-PSA and the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer. Data from preclinical studies suggest that Advaxis’s Lm Technology immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response.

About the Prostate Cancer Foundation

The Prostate Cancer Foundation (PCF) is the world’s leading philanthropic organization funding and accelerating prostate cancer research. Founded in 1993, PCF has raised more than $615 million and provided funding to more than 2,000 research programs at nearly 200 cancer centers and universities. The PCF global research enterprise now extends to 19 countries. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds for transformational cancer research. Its efforts have helped produce a 20-fold increase in government funding for prostate cancer. For more information, click here.

About the Movember Foundation

The Movember Foundation is a global charity raising funds and awareness for men’s health. These funds deliver breakthrough research and support services to allow men to live longer, healthier, happier lives. Since 2003, millions have joined the men’s health movement, raising more than $650 million and funding over 1,000 programs through impact investments, focusing on prostate cancer, testicular cancer and poor mental health.

The Foundation runs awareness and fundraising activities year-round, with the annual Movember campaign in November being globally recognized for its fun and innovative approach to raising money and getting men to take action for their health. During Movember, we challenge men to grow a moustache or to make a commitment to get active and MOVE, both of which are about real action for health and are done to spark conversation and raise vital funds and awareness. The Foundation’s vision is to have an everlasting impact on men’s health.

Movember is fully accredited by the Better Business Bureau, and for the past three years, has been named a Top 100 best NGO by The Global Journal. For more information please visit Movember.com. Movember is a registered 501(c)(3) charity.

About the KEYNOTE-046 Trial

KEYNOTE-046 is a multicenter, dose determining, open-label Phase 1/2 study designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA in approximately 51 mCRPC patients. Part A of the study will be a dose escalating study designed to establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B will consist of a dose escalating trial of ADXS-PSA in combination with KEYTRUDA, followed by an expansion cohort phase. The primary objective is to evaluate safety and tolerability of the two immunotherapies, with the secondary objective to evaluate anti-tumor activity and PFS. Further information about KEYNOTE-046 can be found on ClinicalTrials.gov, using Identifier NCT02325557.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men are expected to die of the disease in 2015.

About ADXS-PSA

ADXS-PSA is an Lm Technology immunotherapy that is designed to target the prostate-specific antigen (PSA), a protein produced exclusively by prostate cells that is associated with prostate cancer. ADXS-PSA secretes the PSA antigen, fused to the powerful immunostimulant tLLO, directly inside the antigen presenting cells that are capable of driving a cellular immune response to PSA expressing cells. This approach is also designed to inhibit the Treg and myeloid-derived suppressor cells (MDSCs) that contribute to immunologic tolerance of prostate cancer. In preclinical analysis, ADXS-PSA inhibits the immunosuppression caused by Treg and MDSC cells localized inside tumors that may promote immunologic tolerance of prostate cancer.

On August 5, 2015 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, reported financial results for the second quarter 2015 ended June 30, 2015 and provided an update on its pipeline (Press release, Loxo Oncology, AUG 5, 2015, View Source [SID:1234507019]).

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"Over the last several months, Loxo has delivered important advances against our pipeline priorities," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "Last week, we achieved an important milestone with the peer-reviewed publication of the first clinical response to LOXO-101, our tropomyosin receptor kinase (TRK) inhibitor. This important early result validates the potential of Loxo’s drug development approach – that selective, purpose-built medicines in genetically well-defined populations can show dramatic and early evidence that justifies continued and rapid drug development. Today we are excited to announce plans for a Phase 2 trial for this program, which accelerate development timelines ahead of previous plans. In addition, we have made significant progress with our preclinical pipeline, allowing us to prioritize our Rearranged during Transfection (RET) and our isoform-sparing Fibroblast Growth Factor Receptor (FGFR) programs, positioning them as our likely next IND filings."

Program Updates

Loxo provided the following updates on its development programs:

LOXO-101: the only potent, oral, selective inhibitor of the TRK family of proteins

Clinical Validation for LOXO-101 Published in Cancer Discovery

The research brief published on July 27, 2015 in Cancer Discovery provides early clinical validation of LOXO-101 against TRK fusion cancer.

The publication, authored in collaboration with Foundation Medicine, Inc. and the Doebele Research Lab at the University of Colorado, includes the case study of the first TRK fusion patient treated in the Phase 1 trial of LOXO-101. A woman with advanced soft tissue sarcoma widely metastatic to the lungs enrolled on study and experienced substantial tumor regression, with imaging studies after one month demonstrating a partial response (PR) as defined by standard RECIST 1.1 criteria. The patient’s shortness of breath rapidly resolved and she was able to discontinue her supplemental oxygen and resume activities of daily living. As discussed in the publication, with four months of treatment, additional CT scans demonstrated almost complete tumor disappearance of the largest tumors. After four months of dosing, the patient did not have any adverse events that were attributed to LOXO-101.

The publication also describes novel assays for assessing LOXO-101’s impact on TRK signaling, patient-derived TRK fusion models in vitro and in vivo which illustrate LOXO-101’s TRK inhibition, and the first-ever description of the molecular epidemiology of TRK fusions in soft tissue sarcoma.

LOXO-101 Phase 2 Trial to Open in the Second Half of 2015

Based on evidence from the Phase 1 trial, including drug exposures that exceeded expectations, Loxo plans to initiate a Phase 2 trial in the second half of this year, earlier than previously anticipated. The trial will be a multicenter, international Phase 2 open label study in adult cancer patients whose tumors harbor TRK fusions. Loxo will provide additional details on the timing, size, and design of the Phase 2 trial after the first clinical site is open.
Loxo believes that a wide variety of tumor types harbor TRK fusions, and plans to work creatively with clinical partners to identify patients with these genetic alterations. Loxo will provide additional details on these plans after the first clinical site of the Phase 2 trial is open.

LOXO-101 Phase 1 Update

In the ongoing Phase 1 study, LOXO-101 continues to consistently achieve systemic drug exposures anticipated to inhibit TRK signaling by over 90%.
Loxo anticipates presenting additional data from the Phase 1 study at a leading medical meeting likely by the first half of 2016.
An update on the future direction of the ongoing Phase 1 trial will be provided in conjunction with the start of the Phase 2 trial.

Pre-clinical Programs

Prioritization of RET and FGFR Programs

Loxo’s collaboration with Array BioPharma continues to generate compelling and differentiated chemical matter. Loxo has used its multi-target, prioritize-by-success collaboration structure to focus on RET and FGFR.
Activating fusions and mutations in RET have been identified across a range of cancer histologies. Loxo is designing a highly specific RET inhibitor that optimizes on-target potency for RET fusions, activating mutations, and anticipated resistance mutations.
Activating fusions and mutations in FGFR3 and FGFR2 have also been identified across a range of cancer histologies. However, most small molecule FGFR inhibitors are functionally equipotent against isoforms FGFR1, FGFR2 and FGFR3, and are associated with metabolic and systemic toxicities that limit dose, duration of therapy and target engagement. Loxo is designing an FGFR1-sparing inhibitor that has the potential to avoid many of the side effects that have been endemic to the FGFR class.
Consistent with prior guidance, Loxo has submitted preclinical data abstracts for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting in November 2015 in Boston, MA. These data will provide evidence of some of the clinically-differentiating features of these programs. Loxo will provide IND guidance for one of these programs by the end of 2015.

Loxo has elected not to file an IND in the first half of 2016 on either of the two unnamed preclinical programs discussed in previous announcements. These programs have identified lead candidates, but still require additional target validation to merit clinical investigation, in the opinion of the Loxo scientific advisory board and management.

Second Quarter 2015 Financial Results

As of June 30, 2015 Loxo had aggregate cash, cash equivalents and investments of $101.8 million, compared to $112.9 million as of December 31, 2014.

The Company continues to expect cash burn of $30-$33 million in 2015, and based on the current operating plan, the Company believes existing capital resources will be sufficient to fund anticipated operations into 2017.

Research and development expenses were $5.7 million for the second quarter 2015 compared to $2.7 million for the second quarter 2014. The increase was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized R&D-related stock-based compensation expense of $0.9 million during the second quarter of 2015 compared to $0.3 million for the second quarter of 2014.

Research and development expenses were $9.5 million for the six months ended June 30, 2015 compared to $4.8 million for the six months ended June 30, 2014. The increase was primarily due to expanded clinical development activities for LOXO-101 and additional full-time equivalents and other support dedicated to discovery, preclinical, and manufacturing activities at Array BioPharma. The Company also recognized R&D-related stock-based compensation expense of $1.4 million during the six months ended June 30, 2015 compared to $0.3 million for the six months ended June 30, 2014.

General and administrative expenses were $2.4 million for the second quarter 2015 compared to $1.2 million for the second quarter 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The Company also recognized G&A-related stock-based compensation expense of $0.8 million during the second quarter of 2015 compared to $0.2 million for the second quarter of 2014.

General and administrative expenses were $4.8 million for the six months ended June 30, 2015 compared to $2.0 million for the six months ended June 30, 2014. The increase was primarily due to additional full-time equivalents, increased compensation costs and increased costs associated with operating as a public company. The Company also recognized G&A-related stock-based compensation expense of $1.3 million during the six months ended June 30, 2015 compared to $0.2 million for the six months ended June 30, 2014.

Net loss attributable to common shareholders was $8.1 million and $14.2 million for the three and six months ended June 30, 2015, respectively, compared to $3.9 million and $6.8 million for the three and six months ended June 30, 2014, respectively.

On August 05, 2015 ArQule, Inc. (Nasdaq:ARQL) reported its financial results for the second quarter of 2015 (Press release, ArQule, AUG 5, 2015, View Source [SID:1234507015]).

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For the quarter ended June 30, 2015, the Company reported a net loss of $4,017,000 or $0.06 per share, compared to a net loss of $6,339,000 or $0.10 per share, for the second quarter of 2014. For the six-month period ended June 30, 2015, the Company reported a net loss of $8,568,000 or $0.14 per share, compared to a net loss of $13,480,000 or $0.22 per share for the six-month period ended June 30, 2014.

At June 30, 2015, the Company had a total of $48,001,000 in cash, equivalents and marketable securities.

Key Highlights

Phase 3 METIV-HCC trial for tivantinib progressing as expected: Enrollment in the pivotal Phase 3 trial for tivantinib in hepatocellular carcinoma (HCC) continues on track to complete patient accrual by year end. The trial targets a biomarker-defined patient population, is randomized 2:1 and will enroll approximately 300 patients with the primary end-point of overall survival.

Phase 2 trial for ARQ 087 in intrahepatic cholangiocarcinoma (iCCA) begins enrollment: The Phase 2 trial in iCCA with ARQ 087 follows the observation of two confirmed partial responses in this patient population in the Phase 1 portion of the program. ARQ 087 is a small molecule, multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family. The FGFR2 gene fusion is a pre-defined biomarker being used to enroll patients in the trial.

Positive feedback from the FDA on the Phase 1 trial for ARQ 092 in Proteus syndrome: Our collaborators at the National Institute of Health (NIH) received positive feedback from the FDA on the design of the Phase 1 trial for Proteus syndrome, and we expect the IND to be filed imminently. ARQ 092 is a small molecule designed to inhibit the AKT serine/threonine kinase. Proteus syndrome is a rare disease driven by the AKT1 mutation.

Increasing signs of efficacy in our Phase 1b trial for ARQ 092 in oncology: A Phase 1b trial is on-going in lymphoma, endometrial and other cancers harboring the AKT1 mutation. ARQ 092 continues to produce single agent responses, most recently in a breast cancer patient harboring the AKT1 mutation.

"We continue to be pleased with the robust rate of enrollment in the METIV-HCC trial with tivantinib as second-line therapy in MET-high HCC patients," said Paolo Pucci, chief executive officer of ArQule. "In addition, recent data from an investigator-initiated, Phase 2 study of tivantinib in combination with cetuximab in MET-high, KRAS wild-type metastatic colorectal cancer presented by Dr. Lorenza Rimassa at the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer further underscores the therapeutic activity of tivantinib in the MET-high patient population."

"ArQule’s proprietary pipeline continues to mature," said Dr. Brian Schwartz, head of research and development. "Our AKT inhibitor, ARQ 092, is on track to enroll its first patient in the third quarter in the Phase 1 trial in Proteus syndrome, a rare disease that is caused by a mutation in the AKT1 gene. Moreover, in the oncology portion of the ARQ 092 clinical program we have observed five patients with confirmed partial responses, four of which came in the Phase 1b enriched cohort and two of which had the same AKT1 mutation which occurs in Proteus syndrome. This is an evolving story that we continue to pursue."

"In all of our studies, with tivantinib, ARQ 087 and ARQ 092, our strategy of conducting biomarker driven clinical trials with small molecules in areas of high unmet need demonstrates our leadership in precision medicine and more importantly our commitment to deliver therapies for our patients on an expedited basis," said Mr. Pucci.

Revenues and Expenses

The Company reported research and development revenue of $3,004,000 for the quarter ended June 30, 2015, compared with $2,901,000 for the quarter ended June 30, 2014. For the six-month period ended June 30, 2015, research and development revenue for the company was $5,789,000, compared with $5,577,000 for the six-month period ended June 30, 2014.

Research and development revenue in the three and six months ended June 30, 2015 is comprised of revenue from the Daiichi Sankyo tivantinib development agreement and the Kyowa Hakko Kirin exclusive license agreement for tivantinib. The revenue increase in the three and six month periods is due to higher revenue from our Daiichi Sankyo tivantinib program.

Total costs and expenses for the quarter ended June 30, 2015 were $7,103,000 compared to $9,307,000 for the second quarter of 2014. For the six-month period ended June 30, 2015, total costs and expenses were $14,703,000 compared with $19,288,000 for the six-month period ended June 30, 2014.

Research and development costs for the three and six months ended June 30, 2015 were $4,327,000 and $8,740,000 respectively, compared with $6,236,000 and $12,967,000 for three and six-month periods of 2014.

Research and development expense in the quarter ended June 30, 2015 decreased by $1.9 million primarily due to lower labor related costs of $0.8 million related to the August 2014 restructuring, outsourced clinical and product development costs of $0.4 million, lab expenses of $0.3 million, and facility costs of $0.3 million.

Research and development expense in the six months ended June 30, 2015 decreased by $4.3 million primarily due to lower labor related costs of $1.7 million related to the August 2014 restructuring, outsourced clinical and product development costs of $1.1 million, lab expenses of $0.6 million, facility costs of $0.5 million and other costs of $0.3 million.

General and administrative expense for three and six-month periods ended June 30, 2015 were $2,776,000 and $5,963,000 respectively, compared to $3,071,000 and $6,321,000 for the three and six-month periods of 2014. General and administrative expense decreased in the three and six months ended June 30, 2015 principally due to lower non-cash stock compensation cost.

On August 5, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) reported financial results for the second quarter of 2015, including revenue from sales of Iclusig (ponatinib) (Press release, Ariad, AUG 5, 2015, View Source;p=RssLanding&cat=news&id=2075920 [SID:1234507014]). The Company also provided an update on key corporate initiatives and clinical-trial plans.

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"During the second quarter, the Company continued strong commercial execution of Iclusig with double-digit percentage, quarter-over-quarter growth in both the U.S. and European markets. We expect additional commercial launches and positive pricing and reimbursement decisions in several European countries during the remainder of the year," said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.

"With our recently announced non-dilutive synthetic-royalty financing, we are able to maximize the value of brigatinib by accelerating to early next year the start of a randomized front-line trial of brigatnib vs. crizotinib," he continued. "This trial is one of four randomized clinical trials that we expect to begin within the next two to three quarters. In addition, we are on track to achieve full patient enrollment in the ALTA pivotal trial of brigatinib in refractory non-small cell lung cancer (NSCLC), which will form the basis for an NDA filing in third quarter of next year."

2015 Second Quarter Financial Results

Revenues

Net product revenues from sales of Iclusig were $27.8 million for the quarter ended June 30, 2015, an increase of 134% vs. the second quarter of 2014 and 16% vs. the first quarter of 2015. These Iclusig product revenues are comprised of revenues of $21.6 million in the U.S. and $6.2 million in Europe. U.S. sales of Iclusig increased 16% from the first quarter to the second quarter of 2015, and European sales increased 19%.

Shipments of Iclusig to patients in France were $2.5 million for the second quarter of 2015. Cumulative total shipments in France, taking into account the impact of foreign exchange, totaled $20.8 million through June 30, 2015. We will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations in France, net of any amounts that will be refunded to the French health authorities as a result of such negotiations, which we anticipate will be completed in the fourth quarter of 2015.

Net Loss

Net loss for the quarter ended June 30, 2015 was $63.2 million, or $0.33 per share, compared to a net loss of $56.9 million, or $0.30 per share, for the same period in 2014.

Research and development (R&D) expenses were $38.7 million for the second quarter of 2015, an increase of 22% compared to the second quarter of 2014. This reflects an increase in costs for our ongoing Phase 2 ALTA trial of brigatinib and NDA-enabling pharmacology and manufacturing activities, as well as an increase in personnel and other costs in support of our continuing Iclusig R&D activities.

Selling, general and administrative (SG&A) expenses were $48.6 million for the second quarter of 2015, an increase of 42% compared to the second quarter of 2014. This reflects an increase in personnel costs, including the impact of severance and related costs associated with the retirement of our chief executive later this year ($2.6 million for the quarter) and an increase in legal and consulting costs, including costs associated with the preparation of this year’s proxy and related initiatives ($4.9 million for the quarter).

Cash Position

As of June 30, 2015, cash and cash equivalents totaled $273.9 million, compared to $352.7 million at December 31, 2014.
Financial Guidance for 2015

Our guidance for revenues from sales of Iclusig remains unchanged. We expect Iclusig revenues for 2015 to be in the range of $130 million to $140 million.

We now expect total R&D expenses for 2015 to be in the range of $177 million to $183 million, compared to our previous guidance of $185 million to $195 million. The decrease in R&D expenses is primarily attributable to a reclassification in our forecast of certain expenses from R&D to SG&A to be consistent with our financial-statement classification of such expenses.

Additionally, we expect total SG&A expenses for 2015 to be in the range of $166 million to $172 million, compared to our previous guidance of $135 million to $145 million for 2015. The increase in SG&A expenses is primarily attributable to the above-noted reclassification of certain expenses, as well as legal and consulting costs associated with this year’s proxy and related initiatives ($6.7 million), and severance and related costs associated with the retirement of our chief executive by year-end ($7.5 million), all of which are non-recurring expenses.

As a result of the revised R&D and SG&A guidance and the $50 million in funding received from PDL BioPharma, Inc. in July 2015 pursuant to a synthetic-royalty financing, we expect our cash and cash equivalents at December 31, 2015 to be at least $240 million.

Recent Progress and Key Objectives

Commercialization of Iclusig

Approximately 145 new patients were treated with Iclusig in the U.S. during the second quarter of 2015, an increase of 22% compared to the first quarter of 2015.
At the end of the second quarter, there were approximately 870 unique prescribers of Iclusig in the U.S., an increase in the prescriber base of approximately 16% from the first quarter of 2015.
In Europe, we are now promoting Iclusig in the United Kingdom, France, Germany, Italy, Austria, Switzerland, The Netherlands, Luxembourg, Denmark, Norway, and Sweden. In addition, Iclusig is available for purchase and is being supplied through named-patient programs and prior authorizations in Spain, Portugal, Finland, Ireland, Turkey, and in several markets in Eastern Europe. Prior to the end of the year, we expect additional pricing and reimbursement decisions and commercial launches in additional markets across the European region.

In June, we announced a commercialization agreement with Paladin Labs Inc., a Canadian specialty pharmaceutical company, to distribute Iclusig in Canada for patients with Philadelphia chromosome-positive leukemias. We expect commercial launch of Iclusig in Canada during the third quarter of this year.

Iclusig Clinical Development

Three randomized Iclusig clinical trials are set to begin in 2015, two of which will evaluate Iclusig in earlier lines of treatment, as follows:
A Phase 3 trial of Iclusig in approximately 500 patients with chronic-phase chronic myeloid leukemia (CP-CML), who have experienced treatment failure after imatinib therapy.
A dose-ranging trial of Iclusig in approximately 450 patients with CP-CML, who have become resistant to at least two prior TKIs.
An early-switch trial of Iclusig in approximately 1,000 patients with CP-CML in the United Kingdom (known as the SPIRIT3 trial).

Brigatinib Clinical Development

Brigatinib is currently being evaluated in the global, Phase 2 pivotal ALTA trial that we anticipate will form the basis for its initial regulatory approval. We are on track to achieve full patient enrollment of approximately 220 patients in the third quarter of 2015 and to file for approval of brigatinib in the U.S. in the third quarter of 2016.
We recently announced a non-dilutive synthetic-royalty financing with PDL BioPharma, Inc., which provides the Company with increased financial flexibility to accelerate clinical development of brigatinib, as well as to support brigatinib commercial readiness. A randomized front-line clinical trial of brigatinib is now set to begin in early 2016. This Phase 3 trial will compare brigatinib and crizotinib in approximately 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.

Advancing the Pipeline

At the end of 2014, we nominated our next internally discovered development candidate, AP32788. This orally active TKI has a unique profile against a validated class of mutated targets in NSCLC and certain other solid tumors and may address an important unmet medical need.
We are on track to file an investigational new drug (IND) application for AP32788 by year-end 2015 and to begin a Phase 1/2 proof-of-concept clinical trial in 2016.

Today’s Conference Call at 8:30 a.m. ET

We will hold a live webcast and conference call of our second quarter 2015 financial results this morning at 8:30 a.m. ET. The live webcast can be accessed by visiting the investor relations section of the Company’s website at View Source The call can be accessed by dialing 888-311-8173 (domestic) or 330-863-3376 (international) five minutes prior to the start time and providing the pass code 76034435. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.