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Iovance Biotherapeutics Reports Second Quarter 2017 Financial Results

On August 1, 2017 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported its second quarter 2017 financial results and provided a corporate update (Press release, Iovance Biotherapeutics, AUG 1, 2017, View Source;p=irol-newsArticle&ID=2290726 [SID1234519981]).

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"During the second quarter of 2017, we made significant progress with our robust immuno-oncology pipeline based on our TIL technology, and reached important milestones. Patient dosing is now ongoing in two of our three Phase 2 programs and we initiated dosing patients in cohort 2 of our C-144-01 metastatic melanoma study, which allows for administration of LN-144 generated through a shorter manufacturing process," said Dr. Maria Fardis, Ph.D., MBA, Chief Executive Officer of Iovance Biotherapeutics. "In addition, we presented encouraging interim data at ASCO (Free ASCO Whitepaper) in June from cohort 1 of our ongoing C-144-01 Phase 2 study in metastatic melanoma. The responses were presented by overall response rate and disease control rate in a heavily pre-treated patient population. This data also demonstrated that we can manufacture TIL at our central GMP facilities and treat a patient population with a high unmet medical need at multiple clinical sites. We plan on selecting the optimal manufacturing process for our clinical programs based on the available data from the C-144-01 study, by the end of 2017.

Second Quarter 2017 and Recent Highlights and Anticipated Milestones

Corporate News:

Corporate name changed to Iovance Biotherapeutics: In June, the Company changed its corporate name from Lion Biotechnologies, Inc. to Iovance Biotherapeutics, Inc. This new name better represents the company’s leadership in the field of immuno-oncology and reflects the recent advancements in evaluating TIL therapy in new indications as well as initiatives to begin trials in Europe.

Seeking patents for recent advancements in TIL technology: Iovance has filed for patent protection on its generation 2 TIL manufacturing process, methods of using TIL therapies, as well as other technologies that can lead to production of better TIL products.
Clinical Trial Progress:

Patient dosing began in second cohort of C-144-01 Phase 2 metastatic melanoma study: In May, the Company began patient dosing in the second cohort of its ongoing Phase 2 trial investigating LN-144 for the treatment of patients with metastatic melanoma. This cohort has a shorter manufacturing process, and reduces the time from excision to infusion from approximately six weeks to just over three weeks, by utilizing the company’s generation 2 manufacturing process which includes cryopreservation of the outbound products. Cryopreservation of the product offers greater flexibility for physicians and patients in scheduling the time of the infusion, and the shorter process increases the manufacturing flexibility leading to lower production costs.

Two Phase 2 trials investigating LN-145 are underway: In June, the Company began patient dosing in its Phase 2 trial of LN-145 for the treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. The Company is also actively screening patients in the Phase 2 trial for LN-145 in cervical cancer.

New Clinical Grant Agreement with Moffitt Cancer Center for trial in lung cancer: In July, Iovance entered into a new Clinical Grant Agreement with the Moffitt Cancer Center to fund a Phase 1 clinical trial of TIL therapy in combination with nivolumab in metastatic non-small cell lung cancer (NSCLC) in an effort to continue to understand the potential power of TIL technology to treat various cancers in areas of high unmet medical need.
Manufacturing Updates:

Technology transfer initiated at PharmaCell in the Netherlands (now Lonza) for generation 1 and 2 TIL manufacturing processes: In anticipation of the initiation of clinical studies in Europe in early 2018, a technology transfer for both the generation 1 and 2 TIL manufacturing processes was commenced at PharmaCell.

Increasing manufacturing capacity: Manufacturing at Wuxi, in suites capable of manufacturing late-stage clinical and commercial products, was initiated in May.
Regulatory News:

Expansion of clinical trials globally: The Company engaged local health authorities in Europe to seek feedback in support of submission of a Clinical Trial Authorisation for melanoma and cervical cancer studies in that region.
Data Presentations:

Interim data presented at ASCO (Free ASCO Whitepaper) highlighting first cohort in ongoing C-144-01 study: The Company presented a poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017 with data from 16 patients enrolled in the first cohort of its ongoing Phase 2 study of LN-144 for the treatment of metastatic melanoma. The data reported showed clinically-meaningful outcomes, of the evaluable patients, with a 29% ORR including one complete response continuing beyond 15 months post-administration of a single TIL treatment, and 77% of patients reported a reduction in target tumor size. The Phase 2 study was conducted in a heavily pre-treated patient group, all of which had received prior anti-PD-1 therapy and 88% with prior anti-CTLA-4 checkpoint inhibitors, with a median of three prior therapies. For the full data, please view the release here.

Data to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain in September 2017: Data will be presented at the upcoming ESMO (Free ESMO Whitepaper) congress demonstrating phenotypic and functional characterization of TIL grown from lymphoma tumors.
Second Quarter 2017 Financial and Operating Results

As of June 30, 2017, the Company held $129.0 million in cash and cash equivalents and short-term investments, compared to $166.5 million as of December 31, 2016.

In connection with hiring Maria Fardis Ph.D. as the new Chief Executive Officer, on June 1, 2016 the Company granted to Dr. Fardis 550,000 non-transferrable restricted stock units as an inducement of employment pursuant to the exception to The NASDAQ Global Market rules. The 550,000 restricted stock units vest in installments as follows: (i) 137,500 restricted stock units vested June 1, 2017; (ii) 275,000 restricted stock units vested upon the satisfaction of certain clinical and manufacturing milestones; and (iii) the remaining 137,500 restricted stock units will vest in equal monthly installments over the 36-month period after June 1, 2017.

The Company is providing both GAAP and non-GAAP financial information. All non-GAAP information excludes amounts related to stock-based compensation. See "Use of Non-GAAP Financial Measures" below for a description of the Company’s non-GAAP Financial Measures. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

GAAP and Non-GAAP Net Loss

GAAP net loss for the quarter ended June 30, 2017 was $23.4 million, or ($0.37) per share, compared to GAAP net loss of $11.6 million or ($0.23) per share for the quarter ended June 30, 2016.

Non-GAAP net loss for the quarter ended June 30, 2017 was $20.1 million, or ($0.32) per share, compared to non-GAAP net loss of $6.2 million, or ($0.13) per share for the quarter ended June 30, 2016. The non-GAAP net loss for the quarters ended June 30, 2017 and June 30, 2016 excludes $3.3 million and $5.4 million of non-cash stock-based compensation, respectively.

GAAP net loss for the six months ended June 30, 2017 was $44.1 million, or ($0.71) per share, compared to GAAP net loss of $18.5 million or ($0.37) per share for the six months ended June 30, 2016. Non-GAAP net loss for the six months ended June 30, 2017 was $37.5 million, or ($0.60) per share, compared to non-GAAP net loss of $11.3 million or ($0.23) per share for the six months ended June 30, 2016.

GAAP and Non-GAAP Expenses

GAAP research and development (R&D) expenses were $19.7 million for the quarter ended June 30, 2017, an increase of $15.2 million compared to the quarter ended June 30, 2016. The increase in R&D expense is due to increased spending on clinical activities and manufacturing. In addition, R&D-associated stock based expenses were $1.9 million for the three months ended June 30, 2017 and $3.3 million for the six months ended June 30, 2017. Non-GAAP R&D expenses were $17.8 million for the quarter ended June 30, 2017, an increase of $13.9 million, compared to $3.9 million for the quarter ended June 30, 2016.

GAAP general and administrative (G&A) expenses were $3.9 million for the quarter ended June 30, 2017, a decrease of $3.4 million compared to the quarter ended June 30, 2016. Non-GAAP G&A expenses for both quarters ended June 30, 2017 and June 30, 2016 remained unchanged at $2.5 million.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, generally accepted accounting principles, or GAAP, and may be different from non-GAAP financial measures used by other companies. The item included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release relates to the non-cash stock-based compensation expense which may fluctuate from period to period based on factors including the timing and accounting of grants for stock options and changes in the Company’s stock price which impacts the fair value of options granted. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding various financial and business trends relating to the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of Iovance’s ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating operational performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. To the extent this release contains historical or future non-GAAP financial measures, the Company has also provided corresponding GAAP financial measures for comparative purposes. Reconciliation between certain GAAP and non-GAAP measures is provided at the end of this press release.

AIMM signs exclusive license and option agreement with Merck & Co., Inc., Kenilworth, NJ, USA on preclinical oncology targets

On August 1, 2017 AIMM Therapeutics BV, an oncology focused developer of novel tumor specific therapeutic antibodies sourced directly from elite responders to immune therapy or from immunized animals, reported that it has entered into an exclusive license and option agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) regarding a series of AIMM’s tumor specific antibodies directed against an undisclosed target expressed on many different tumor types (Press release, AIMM Therapeutics, AUG 1, 2017, View Source [SID1234521097]). In addition, MSD has an exclusive option on a second series of AIMM’s tumor specific antibodies directed against a different tumor target.

Under the terms of the agreement between AIMM and MSD, through a subsidiary, MSD will make an undisclosed upfront payment and future success-based payments. MSD will be responsible for development, manufacturing and commercialization. Additional details were not disclosed.

“We are excited that MSD, as a leader in the field of immuno-oncology, recognizes the unique synergy and clinical potential offered by AIMM’s tumor specific antibodies in combination with KEYTRUDA (pembrolizumab) for cancer patients who have limited or no responses to checkpoint inhibitors alone” said Jan de Vries, AIMM’s CEO.

Spectrum Pharmaceuticals Announces Completion of Enrollment in the Phase 3 Pivotal Study (ADVANCE) of ROLONTIS™ (eflapegrastim), a Novel Long-Acting GCSF

On August 1, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported the Company has completed enrollment with 405 patients randomized in the ROLONTIS Phase 3 ADVANCE pivotal study under a Special Protocol Assessment (SPA) with the Food and Drug Administration (Press release, Spectrum Pharmaceuticals, AUG 1, 2017, View Source [SID1234519979]). The study is evaluating the safety and efficacy of ROLONTIS in the management of chemotherapy-induced neutropenia in patients with breast cancer.

"I am pleased to report that we have been able to complete enrollment in the ADVANCE study ahead of schedule," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We plan to announce topline data early next year and expect to file a BLA in 2018. RECOVER, the second Phase 3 study for ROLONTIS, is a smaller study that will include sites in the U.S. and Europe, and is currently enrolling patients. RECOVER will leverage established relationships with U.S. sites from the ADVANCE study to help expedite enrollment. We believe ROLONTIS, if approved by the FDA, has the opportunity to change the growth trajectory of our Company because it targets a multi-billion dollar market and our team has a deep knowledge and understanding of the space. We are excited to be in the final stages of what could be a transformational development for the Company."

Spectrum is conducting a second Phase 3 study, RECOVER, which is a multicenter, randomized, active-controlled study similar in design to the ADVANCE study that is currently enrolling in the U.S. and Europe. This study will enroll approximately 218 early-stage breast cancer patients, who will receive adjuvant or neoadjuvant TC (docetaxel and cyclophosphamide) chemotherapy every 21 days for up to 4 cycles. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term, disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to help shrink the tumor and potentially allow for breast-conserving surgery. The primary study endpoint is the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] < 0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints include the incidence of neutropenic complications, incidence of febrile neutropenia, relative dose intensity, and safety.

Intellia Therapeutics Announces Second Quarter 2017 Financial Results

On August 1, 2017 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR technology, reported financial and operational results for the second quarter of 2017 (Press release, Intellia Therapeutics, AUG 1, 2017, View Source [SID1234519971]).

The company has made significant progress using our proprietary lipid nanoparticle (LNP) delivery system throughout the quarter. We advanced into non-human primate studies, while first time data from rat studies, the second species we tested in vivo, confirmed the durable mouse data demonstrating high levels of sustained genome editing and serum transthyretin (TTR) reduction post-single-dose intravenous administration.

"We are very excited that our initial non-human primate data in vivo continue to validate our mRNA delivery technology. These preclinical data accelerate our momentum as we advance the development of potential therapies to treat patients with high unmet medical needs," said Chief Executive Officer and founder Nessan Bermingham, Ph.D., Intellia Therapeutics. "During the quarter, we have further strengthened our company by advancing partnerships, including a research agreement with Ospedale San Raffaele in Milan for our ex vivo technology focused on novel engineered cell therapies using CRISPR, expanded our global intellectual property portfolio, and appointed two new members to our Board of Directors."

Second Quarter 2017 Operational Highlights

The company achieved several key operational milestones during the second quarter of 2017, including:

Commenced non-human primate studies in support of our preclinical work relating to our lead development program in TTR. We demonstrated robust green fluorescent protein expression throughout non-human primate liver 24 hours after a single systemically delivered administration dose in vivo, using our proprietary lipid nanoparticle delivery system.

Extended our data set beyond the mouse and delivered CRISPR/Cas9 in the rat. Specifically, initial data from rat models post-single-dose intravenous administration in vivo using our proprietary lipid nanoparticle delivery system showed up to 91 percent reduction in serum TTR protein levels and up to 66 percent editing at the target DNA site, demonstrating robust and dose-responsive gene editing of TTR. We presented these results at the American Society of Gene & Cell Therapy Annual Meeting in Washington D.C. in May 2017.

Provided an update on our ongoing durability study, demonstrating durable liver editing through nine-months post a single intravenous dose administration in mice using our proprietary lipid nanoparticle delivery system. Throughout the liver, the data continues to demonstrate durability and high editing efficiency of LNP-mediated editing of the TTR gene, showing 97 percent reduction in serum TTR protein levels and approximately 70 percent editing at the target DNA site. The intended transient nature of LNP delivery has been confirmed in rodents with undetectable Cas9 mRNA and gRNA levels in the liver by 72 hours post administration.

Entered into a three-year research collaboration, option, and license agreement to engineer optimized T cell cancer therapies with a leading scientific research institution, Ospedale San Raffaele SRL of Milan, Italy.
• The collaboration aims to discover innovative targets against tough-to-treat cancers, leveraging Intellia’s proprietary CRISPR/Cas9 platform to generate next-generation T cell therapies to address unmet needs in hematological and solid tumors.
• The collaboration is the first partnership of Intellia’s eXtellia division, focused on advancing next generations of engineered cell therapies through unique and proprietary applications of CRISPR genome editing in areas including immuno-oncology and auto-immunity.

Continued to defend and enhance our CRISPR/Cas9 foundational and therapeutic intellectual property position through filing and prosecution of patent applications covering our internal, collaboration and in-licensed inventions. In relation to the foundational CRISPR/Cas9 genome editing intellectual property portfolio to which we have rights for human therapeutics and companion diagnostics, and which is co-owned by the Regents of the University of California, the University of Vienna, and Dr. Emmanuelle Charpentier (collectively "UC"), the following was achieved:
• China’s State Intellectual Property Office granted to UC a patent broadly covering CRISPR/Cas9 single-guide genome editing methods and compositions. The patent includes claims that cover methods for editing DNA in non-cellular and cellular settings, including in eukaryotic cells such as human and mammalian cells. It also includes CRISPR/Cas9 composition of matter and system claims for use in any setting, including claims covering the use of CRISPR/Cas9 in producing medicines for treating disease.
• UC submitted its opening brief July 25, 2017 to the U.S. Court of Appeals for the Federal Circuit in their appeal from a February 15, 2017 decision by the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board ("PTAB") in an interference proceeding relating to the CRISPR/Cas9 genome editing technology. In the appeal, UC requests the reversal of the PTAB’s decision to terminate the interference between certain CRISPR/Cas9 patent claims owned by UC and patents and patent applications owned by the Broad Institute, Massachusetts Institute of Technology, the President and Fellows of Harvard College and the Rockefeller University.

Named Moncef Slaoui, Ph.D. and Frank Verwiel, M.D. to its Board of Directors. In addition the Board established a Science & Technology Committee:
• Moncef Slaoui, Ph.D. and Frank Verwiel, M.D. joined the Board of Directors. Drs. Slaoui and Verwiel began Board responsibilities on July 25, 2017. Intellia’s Board of Directors also established a Science and Technology Committee, which will be chaired by Dr. Slaoui. Additionally, Carl L. Gordon, Ph.D., CFA, General Partner, OrbiMed Advisors, LLC, informed the company of his resignation from the Intellia Board of Directors effective at the close of business on July 25, 2017.
Second Quarter 2017 Financial Results

Collaboration Revenue

Collaboration revenue was $5.9 million for the second quarter of 2017, compared to $4.2 million for the second quarter of the prior year. The increase in collaboration revenue in 2017 was primarily driven by amounts recognized under our collaboration agreement with Regeneron Pharmaceuticals, Inc. (Regeneron), which was entered into in April 2016.

Through June 30, 2017, the company received $104.1 million in funding under its collaborations with Novartis Institutes for BioMedical Research, Inc. (Novartis) and Regeneron, excluding amounts received for equity investments, and recorded accounts receivable of $2.8 million. Excluding the $2.6 million of the upfront payment received from Novartis, which was allocated to the purchase of equity securities, we recognized $34.7 million in collaboration revenue under these agreements through June 30, 2017, and had remaining deferred revenue of $69.6 million as of June 30, 2017.

Operating Expenses

Research and development expenses increased $8.2 million to $15.6 million during the second quarter 2017, compared to $7.4 million during the same period of 2016. This increase was driven primarily by greater support for the advancement of our early-stage research programs and includes laboratory supplies and research materials. Additionally, salary and related headcount-based expenses increased as the company grew to 110 research and development employees as of June 30, 2017, from 56 research and development employees as of June 30, 2016.

General and administrative expenses increased $2.7 million to $6.4 million during the second quarter of this year, compared to $3.7 million in the second quarter of 2016. This increase was driven primarily by increased salary and related headcount-based expenses as the company grew to 33 general and administrative employees as of June 30, 2017, from 19 general and administrative employees as of June 30, 2016, to support our public company compliance and administration obligations. The company also incurred increased corporate insurance, legal, and other professional expenses related to its expanding operations since becoming a public company in May 2016.

Our net loss was $15.6 million for the second quarter 2017, compared to $6.9 million for the second quarter of 2016.

Balance Sheet

Cash and cash equivalents at June 30, 2017, were $241 million, compared to $301 million for the same quarter in 2016. The base period cash and cash equivalents were primarily attributable to $115.5 million in proceeds from our initial public offering, $55 million in concurrent private placements, and a $75 million upfront payment from Regeneron in April 2016. The year-over-year change is attributed to cash used in ongoing operations.

Financial Guidance

Our primary uses of capital will continue to be research and development programs, laboratory and related supplies, compensation and related expenses, legal and other regulatory expenses, patent prosecution, filing and maintenance costs for our licensed intellectual property, and general overhead costs.

During 2017, the company expects expenses to continue to increase compared to prior periods relating to our ongoing activities, particularly as research and development and preclinical activities gather further momentum toward human clinical trials, and we spend a full year occupying our new office and laboratory facility, which we began to occupy in the fourth quarter of 2016.

As of June 30, 2017, the company had an accumulated deficit of $81.8 million. We expect our losses to increase as we continue to incur significant research and development and other expenses related to the advancement of our therapeutic programs and our ongoing operations. Based on our research and development plans and expectations related to the progress of the company’s programs, we expect that the cash and cash equivalents as of June 30, 2017, as well as technology access and research funding from Novartis and Regeneron, will enable Intellia to fund operating expenses and capital expenditures through mid-2019, excluding any potential milestone payments or extension fees received under our collaboration agreements with Novartis and Regeneron.

Genomic Health Announces Second Quarter 2017 Financial Results and Reports Recent Business Progress

On August 1, 2017 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended June 30, 2017 (Press release, Genomic Health, AUG 1, 2017, View Source [SID1234519966]).

Total revenue was $85.5 million in the second quarter of 2017, compared with $82.0 million in the second quarter of 2016, an increase of 4 percent, and an increase of 5 percent on a constant currency basis.i

U.S. product revenue was $72.4 million in the second quarter of 2017, compared with $69.6 million in the second quarter of 2016. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score test sales was $65.6 million in the second quarter of 2017, compared with $64.4 million in the second quarter of 2016. U.S. prostate revenue from Oncotype DX Genomic Prostate Score (GPS) test sales was $4.1 million in the second quarter of 2017, compared with $2.3 million in the second quarter of 2016.

International product revenue was $13.1 million in the second quarter of 2017, compared with $12.3 million in the second quarter of 2016, an increase of 6 percent, and an increase of 10 percent on a constant currency basis.i

"In the second quarter, we continued to deliver solid results reflecting both the strength and differentiation of our clinical data and unmatched commercial channel, generating a 9 percent increase in test volume and a 4 percent increase in revenue," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Importantly, we delivered operating leverage and made significant progress toward our goal of delivering full-year profitability, having improved net loss by $9 million in the first half of the year."

More than 31,550 Oncotype test results were delivered in the second quarter of 2017, an increase of 9 percent, compared with more than 29,060 test results delivered in the same period in 2016. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 5 percent and Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 38 percent compared with the second quarter of the prior year. International tests delivered grew 12 percent compared with the same period of the prior year and represented approximately 24 percent of total test volume in the second quarter of 2017.

Operating loss for the second quarter of 2017 improved to $3.1 million, compared with $5.1 million for the second quarter of 2016. Net loss was $2.7 million, or 8 cents per share, for the second quarter of 2017, compared with a net loss of $6.1 million, or 18 cents per share, for the second quarter of 2016. Basic and diluted net loss per share was $0.08 for the second quarter of 2017, compared with basic and diluted net loss per share of $0.18 for the second quarter of 2016.

Total revenue for the six months ended June 30, 2017 was $169.5 million compared with $162.9 million for the six months ended June 30, 2016, an increase of 4 percent. On a constant currency basis, revenue increased 5 percent compared with the same period in the prior year.i

International product revenue was $26.5 million for the six months ended June 30, 2017, compared with $22.7 million for the six months ended June 30, 2016, an increase of 16 percent, and an increase of 20 percent on a constant currency basis.i

Operating loss improved to $6.0 million for the six months ended June 30, 2017 compared with an operating loss of $13.9 million for the six months ended June 30, 2016. Net loss was $3.5 million for the six months ended June 30, 2017 compared with a net loss of $12.5 million for the six months ended June 30, 2016.

Cash and cash equivalents and short-term marketable securities at June 30, 2017 were $109.8 million, compared with $87.7 million at December 31, 2016 excluding the fair value of the company’s investment in a marketable security of $9.3 million.

2017 Financial Outlook

The company is providing the following adjusted financial guidance for the full year ending December 31, 2017:

·
Total revenue of between $345 to $355 million (formerly $355 to $370 million); and
·
Profit for the full-year at either end of revenue range (formerly profit at revenue above $362.5 million).

"While the timing of important reimbursement drivers has delayed the pace of revenue growth, we expect to deliver full-year profitability at these revised revenue levels, including double-digit revenue growth in the fourth quarter," said Brad Cole, chief operating officer and chief financial officer of Genomic Health. "We expect full-year CMS intermediate prostate coverage and the implementation of both PAMA reimbursement rates and AJCC staging criteria, along with increased global market penetration, to drive strong revenue growth in 2018."

Recent Business Highlights

·
Presented new results from a large, community-based, multi-center clinical validation study conducted at Kaiser Permanente at the American Urological Association (AUA) 2017 Annual Meeting. The results confirmed that the Oncotype DX GPS test is a strong independent predictor of prostate cancer-specific death and disease progression (metastases) at 10 years in men with localized prostate cancer.
·
Data from two Oncotype DX GPS test analyses based on a prospective, multi-center, 1,200-patient study were also presented at AUA, including results that represent the first-ever prospective validation of a tissue-based molecular marker in prostate cancer. The second analysis, presented at AUA and published online in Urology, reinforced that the GPS test significantly increases use of and persistence on active surveillance.
·
Initiated an early access Clinical Utility Program for select centers around the country in preparation for the commercial launch of the Oncotype DX AR-V7 Nucleus Detect test in collaboration with Epic Sciences.
·
The 15th St. Gallen International Breast Cancer Conference Expert Panel published updated guidelines endorsing the Oncotype DX Breast Recurrence Score test for guiding treatment decisions on adjuvant chemotherapy in both node-negative and node-positive patients (up to three nodes).

·
Breast Cancer Research and Treatment published positive five-year clinical outcome results from the PlanB study led by the West German Study Group (WSG) in 93 centers across Germany. The study showed that women with Recurrence Score results of 11 or less who were treated with hormonal therapy alone had excellent outcomes with 94 percent disease-free survival rates at five years despite having high-risk disease by traditional parameters.
·
Presented results from eight studies across breast, prostate and kidney cancers that provide additional evidence of the value of Oncotype DX tests in predicting clinically meaningful endpoints and outcomes across cancer types at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.