On May 9, 2017 Genomic Health, Inc. (Nasdaq: GHDX) reported financial results and business progress for the quarter ended March 31, 2017 (Filing, Q1, Genomic Health, 2017, MAY 9, 2017, View Source [SID1234518947]).

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Total revenue was $84.0 million in the first quarter of 2017, compared with $80.9 million in the first quarter of 2016, an increase of 4 percent.

U.S. product revenue was $70.6 million in the first quarter of 2017, compared with $70.5 million in the first quarter of 2016. U.S. invasive breast revenue was $64.8 million in the first quarter of 2017, compared with $64.1 million in the first quarter of 2016. U.S. prostate revenue was $3.3 million in the first quarter of 2017, compared with $2.6 million in the first quarter of 2016.

International product revenue was $13.4 million in the first quarter of 2017, compared with $10.4 million in the first quarter of 2016, an increase of 29 percent, and an increase of 33 percent on a constant currency basis.i

"Strong demand for our Oncotype tests in the first quarter of 2017 was due, in part, to growth across our U.S. prostate and global invasive breast business, including four percent sequential growth in U.S. invasive breast cancer. Importantly, for the seventh consecutive quarter, we delivered operating leverage and improved operating income by $6 million in the first quarter," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Additionally, last week Palmetto GBA issued a draft local coverage determination that recommends Medicare coverage expansion for the Oncotype DX Genomic Prostate Score to include intermediate-risk patients. Reimbursement progress remains a critical growth driver as we aim to deliver double-digit revenue growth in the second half of the year with continued profitability improvement."

Operating loss for the first quarter of 2017 improved to $2.8 million, compared with $8.8 million for the first quarter of 2016. Net loss was $0.8 million, or 2 cents per share, for the first quarter of 2017, compared with a net loss of $6.4 million, or 19 cents per share, for the first quarter of 2016. Basic and diluted net loss per share was $0.02 for the first quarter of 2017, compared with a basic and diluted net loss per share of $0.19 for the first quarter of 2016.

More than 31,580 Oncotype test results were delivered in the first quarter of 2017, an increase of 7 percent, compared with more than 29,510 test results delivered in the same period in 2016. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 1 percent and Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 40 percent compared with the prior year. International tests delivered grew 17 percent compared with the prior year and represented approximately 25 percent of total test volume in the first quarter of 2017.

Cash and cash equivalents and short-term marketable securities at March 31, 2017 were $94.4 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.

Recent Business Highlights

· Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, issued a draft local coverage determination (LCD) for the Oncotype DX Genomic Prostate Score (GPS) expanding Medicare coverage to include qualified patients with favorable intermediate-risk prostate cancer throughout the United States.

· Presented results from four studies evaluating the clinical validation and utility of the GPS in the management of early-stage prostate cancer at the 2017 Genitourinary (GU) Cancers Symposium. Collectively, these new data highlight the test’s ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network (NCCN) clinical risk groups.

· Presented results from a large multi-center clinical validation study that used a longitudinal patient database from Kaiser Permanente’s Northern California region demonstrating that the GPS predicts 10-year risk of developing metastatic prostate cancer. Designated one of the ‘Best Posters’ at the 32nd Annual European Association of Urology (EAU) Congress, results highlight the expanded value of the test in assessing risk and long-term outcomes in newly diagnosed prostate cancer patients.

· Later this week, additional results from the Kaiser validation study, which also analyzed the GPS performance in predicting prostate cancer-specific death, will be presented at the American Urological Association (AUA) 2017 Annual Meeting.

· Three additional Oncotype DX GPS studies demonstrating prospective and additional clinical utility, including persistence on active surveillance, will also be presented at AUA.

· The German Association of Gynecological Oncology’s (AGO’s) updated treatment guidelines reconfirm Oncotype DX with the highest 1A level of evidence and recognize it as the only multi-gene



breast cancer test available to predict chemotherapy benefit for women with early-stage, hormone-receptor positive, HER2-negative invasive breast cancer.

· Established an agreement with an additional German public health insurance fund, covering 2.5 million lives, to begin offering Oncotype DX to early-stage breast cancer patients.

· Presented results at the 15th St. Gallen International Breast Cancer Conference from 15 Oncotype DX Breast Recurrence Score studies conducted in 12 countries that provide real-world evidence of the test’s ability to change treatment decisions for breast cancer patients.

· The journal Breast Cancer Research and Treatment published results from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Registry, which demonstrated that many node-positive breast cancer patients can avoid chemotherapy based on their Oncotype DX Breast Recurrence Score.

· The Journal of Surgical Oncology published results from a multicenter trial, which demonstrated that the Oncotype DX Breast Recurrence Score can guide neoadjuvant therapy to help facilitate breast-conserving surgery for hormone receptor-positive breast cancer patients.

· Received acceptance to present eight Oncotype DX studies at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.

Conference Call Details

To access the live conference call today, May 9 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada or +1 (224) 357-2389 internationally. The conference ID is 10366777. Please dial in approximately ten minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s website at View Source Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.

On May 9, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its first quarter ended March 31, 2017 (Press release, Foundation Medicine, MAY 9, 2017, View Source [SID1234518946]). Results and business highlights for the quarter included:

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Reported 13,933 clinical tests in the first quarter, 55% year-over-year growth;
Reported first quarter revenue of $26.3 million which included payment for FoundationOne for patients with non-small cell lung cancer (NSCLC) under a Local Coverage Determination (LCD) by Palmetto GBA, the company’s Medicare Administrative Contractor in North Carolina;
Announced a collaboration agreement with Bristol-Myers Squibb in the area of immuno-oncology (IO). BMS will leverage FMI’s molecular information platform to identify predictive biomarkers across multiple tumor types in patients enrolled in clinical trials investigating BMS’ cancer immunotherapies;
Published 27 manuscripts in high-quality, peer-reviewed journals and delivered 37 podium and poster talks at various medical and scientific meetings; and,
Increased FoundationCORE, the company’s molecular information database, to more than 125,000 clinical cases.
"Foundation Medicine achieved several milestones this quarter that extend our leadership in molecular information, including strong growth in clinical volume, payment from Medicare and a collaboration with Bristol-Myers Squibb in the critical field of immuno-oncology," said Troy Cox, chief executive officer of Foundation Medicine. "Importantly, we believe we are on track to achieve our 2017 business objectives, including advancing our universal companion diagnostic assay through the FDA and CMS parallel review process to a decision during the second half of this year."

Foundation Medicine reported total revenue of $26.3 million in the first quarter of 2017, compared to $30.4 million in the first quarter of 2016. Total revenue declined year over year due to an expected decrease in first quarter biopharmaceutical revenue related to the timing of various research and development projects with its biopharma partners. Revenue from biopharmaceutical customers was $14.7 million in the first quarter of 2017 compared to $20.2 million in the first quarter of 2016. The results of 1,802 tests were reported to biopharmaceutical customers in this year’s first quarter.

Clinical revenue returned to year over year growth, partially driven by the receipt of Medicare payment for FoundationOne under Palmetto’s NSCLC LCD. Revenue from clinical testing in the first quarter of 2017 was $11.6 million, compared to $10.2 million in the first quarter of 2016.

The company reported 13,933 tests to clinicians in the first quarter of 2017, a 55% increase from the same quarter last year. This number includes 11,005 FoundationOne tests, 1,284 FoundationOne Heme tests, 1,355 FoundationACT tests, and 289 FoundationFocus CDxBRCA tests.

Total operating expenses for the first quarter of 2017 were approximately $55.0 million compared with $36.5 million for the first quarter of 2016. The increase in operating expenses was partially driven by investments related to the development of the company’s universal companion diagnostic assay. Net loss was approximately $46.5 million in the first quarter of 2017, or a $1.31 loss per share. At March 31, 2017, the company held approximately $99.1 million in cash, cash equivalents and marketable securities.

2017 Outlook

Foundation Medicine’s business and financial outlook for 2017 remains unchanged:

The company expects 2017 revenue will be in the range of $135 million to $145 million.
The company expects to deliver between 53,000 and 56,000 clinical tests in 2017.
The company expects operating expenses will be in the range of $205 million and $215 million.
The company expects to advance its universal, pan-cancer companion diagnostic assay through the FDA and CMS Parallel Review process with a decision in the second half of 2017.
The company expects to expand upon reimbursement progress made in 2016 and drive additional coverage decisions for its CGP assays.

On May 9, 2017 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the first quarter of 2017 and provided an update on the company’s recent developments (Press release, FibroGen, MAY 9, 2017, View Source [SID1234518945]).

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"This is an exciting time for FibroGen, as we prepare for an eventful second half of the year across our pipeline. In the third quarter of 2017, we anticipate reporting topline Phase 2 clinical trial results for pamrevlumab in idiopathic pulmonary fibrosis patients, and we are preparing to complete submission of the roxadustat China NDA for the treatment of anemia in non-dialysis and dialysis CKD patients," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are gratified by the support we received from new and current investors in our recent equity offering, which raised $115.1 million in net proceeds. This financing will support our plans to increase the number of studies and accelerate development in other anemia categories in China, including for roxadustat in anemias in certain oncology settings."

Recent Developments AND HIGHLIGHTS
U.S. Roxadustat for Anemia in Chronic Kidney Disease (CKD)

The independent data safety monitoring board (DSMB) recommended in April that all trials continue with no modifications to current protocols.
On track to submit the NDA for roxadustat in the U.S. in 2018.
U.S. Roxadustat for Anemia in Myelodysplastic Syndromes (MDS)

Received approval from FDA to conduct Phase 3 study for the treatment of anemia in MDS. This study is planned to start in the third quarter of 2017.
China Roxadustat Anemia in CKD: Dialysis and Non-Dialysis

Positive Phase 3 results from two pivotal trials in China were announced on January 30, 2017.
On target for NDA submission in China in the third quarter of 2017.
China Roxadustat for Myelodysplastic Syndromes (MDS)

Received approval from the CFDA to undertake a Phase 2/3 study for the treatment of anemia in MDS. We plan to start this study in the fourth quarter of 2017.
Pamrevlumab in Idiopathic Pulmonary Fibrosis (IPF)

On track to report topline Phase 2 study results from a double-blind, placebo-controlled study, and a double-blind, active-controlled sub-study for the treatment of IPF in the third quarter of 2017.
Pamrevlumab in Pancreatic Cancer

Positive findings from an ongoing open-label, randomized Phase 1/2 study in locally advanced pancreatic cancer were presented at the 2017 Gastrointestinal Cancers Symposium in January.
Positive results from a prior Phase 1/2 trial were published online in January 2017 in the Journal of Cancer Clinical Trials.
Corporate and Financial Highlights

Net loss per basic and diluted share for the quarter ended March 31, 2017 was $0.52, as compared to $0.45 a year ago.
At March 31, 2017, FibroGen had $314.2 million of cash, restricted time deposits, cash equivalents, investments, and receivables.
In addition, we completed an equity financing on April 11, 2017 that generated $115.1 million in net proceeds.

On May 9, 2017 Compugen Ltd. (NASDAQ: CGEN), a therapeutic discovery company, reported financial results for the first quarter ended March 31, 2017 (Filing, Q1, Compugen, 2017, MAY 9, 2017, View Source [SID1234518944]).

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Anat Cohen-Dayag, Ph.D., CEO and President of Compugen, stated, "During this quarter we saw continuing scientific and therapeutic development advancements as well as business development progress in our four focus program areas:
·
COM701, an antibody drug candidate against PVRIG, a novel immune checkpoint target, with the potential to serve for both mono- and combination cancer immunotherapy;
·
COM902, an antibody drug candidate against TIGIT, with a strong biological rationale to work synergistically with COM701 and as a monotherapy treatment for cancer;
·
Multiple novel myeloid target programs for immuno-oncology aiming to expand the patient population responsive to checkpoint inhibitors; and
·
CGEN-15001, an Fc fusion protein candidate based on a novel immune checkpoint target for autoimmune diseases."

Dr. Cohen-Dayag continued, "Our on-going discussions with multiple potential partners indicate that these four program areas are aligned with key market needs and possess significant potential value. Furthermore, we believe each represents a unique and different value proposition for various potential partners and we further believe that at least one new industry partnership is achievable by the end of this year."

Financial Results
R&D expenses for the first quarter of 2017 were $6.7 million, compared with $6.8 million for the comparable period in 2016.

Net loss for the first quarter of 2017 was $8.7 million, or $0.17 per diluted share, compared with a net loss of $8.6 million, or $0.17 per diluted share, in the comparable period of 2016.

As of March 31, 2017, cash, cash related accounts, short-term bank deposits and restricted cash totaled $54.5 million, compared with $61.5 million at December 31, 2016. The Company has no debt.

Conference Call and Webcast Information
Compugen will hold a conference call to discuss its first quarter 2017 results today, May 9, 2017, at 10:00 a.m. ET. To access the live conference call by telephone, please dial 1-888-281-1167 from the US, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website through June 9, 2017.

On May 9, 2017 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the first quarter ended March 31, 2017 (Press release, Celldex Therapeutics, MAY 9, 2017, View Source [SID1234518942]).

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"In the first quarter of 2017, Celldex made considerable progress across our pipeline," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We continue to expect enrollment completion in our ongoing study of glembatumumab vedotin in triple negative breast cancer by the end of September, and we recently completed enrollment in the Phase 2 glembatumumab vedotin plus varlilumab combination cohort in checkpoint-refractory metastatic melanoma. Glemba’s target, gpNMB, is highly expressed in melanoma and triple negative breast cancer, among others, and is associated with more aggressive disease. We believe taking an antibody-drug conjugate approach to targeting gpNMB generates a potent cytotoxic effect within the tumor and its environment and may ultimately result in improved outcomes for patients."

"We also look forward to presenting data from two programs in oral sessions at ASCO (Free ASCO Whitepaper) in June—the Phase 2 single-agent study of glembatumumab vedotin in metastatic melanoma and the Phase 1 combination study of varlilumab and Opdivo."

Recent Highlights

Continued progress in METRIC enrollment: Celldex continues to expect that enrollment will be completed by the end of September 2017. METRIC is a Phase 2b randomized study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB.

Single-agent glembatumumab vedotin Phase 2 study in checkpoint-refractory metastatic melanoma accepted for oral presentation at ASCO (Free ASCO Whitepaper): Updated data from the single-agent cohort of the Phase 2 study will be presented in an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June. Enrollment recently completed in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Enrollment continues in the glembatumumab vedotin plus checkpoint inhibitor (Opdivo or Keytruda) arm in patients who failed prior checkpoint therapy, a population with limited treatment options.

Phase 1 varlilumab/Opdivo study accepted for oral presentation at ASCO (Free ASCO Whitepaper): Updated data from the Phase 1 portion of the varlilumab and Opdivo study will be presented in an oral presentation at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting in June. The Phase 2 portion of the combination study includes cohorts in colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, and is currently enrolling patients. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with Bristol-Myers Squibb to present data from the study at a future medical meeting. Data from the Phase 1 single-agent study of varlilumab in solid tumors were recently published in the Journal of Clinical Oncology.

Phase 1 study of CDX-0158 continues to enroll patients: This dose escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study continue to be expected by year-end 2017.

CDX-3379 advancing to Phase 2: The Company is currently finalizing plans for advancement into a Phase 2 study in combination with cetuximab in patients with cetuximab-resistant advanced head and neck squamous cell carcinoma.

Enrollment ongoing in Phase 1 study of CDX-014: The study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
First Quarter 2017 Financial Highlights and Updated 2017 Guidance

Cash position: Cash, cash equivalents and marketable securities as of March 31, 2017 were $167.0 million compared to $189.8 million as of December 31, 2016. The decrease was primarily driven by our first quarter cash used in operating activities of approximately $35.3 million which included a payment of $4.7 million in accrued amounts to a vendor of Kolltan. This obligation was assumed in the Kolltan acquisition. This decrease was partially offset by the receipt of $12.8 million from sales of our common stock under our Cantor agreement. At March 31, 2017, Celldex had 124.2 million shares outstanding.

Revenues: Total revenue was $1.5 million in the first quarter of 2017, compared to $1.3 million for the comparable period in 2016. The increase in revenue was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $25.8 million in the first quarter of 2017, compared to $27.4 million for the comparable period in 2016. The decrease in R&D expenses was primarily due to a decrease in Rintega product development expenses of $7.3 million, partially offset by increases in glembatumumab vedotin, CDX-0158 and CDX-3379 product development expenses of $1.8 million, $0.8 million and $0.7 million, respectively, and increases in personnel and facility costs related to the Kolltan acquisition.

G&A Expenses: General and administrative (G&A) expenses were $7.2 million in the first quarter of 2017, compared to $9.3 million for the comparable period in 2016. The decrease in G&A expenses was primarily due to a decrease in Rintega commercial planning costs of $2.0 million.

Loss on Fair Value Remeasurement of Contingent Consideration: In connection with the Kolltan Acquisition, we agreed to pay Kolltan’s stockholders milestone payments of up to $172.5 million in the event that certain specified preclinical and clinical development milestones related to Kolltan’s development programs and/or our development programs and certain commercial milestones related to Kolltan’s drug candidates are achieved. These milestone payments may be made in cash, in shares of our common stock or a combination of both, subject to NASDAQ listing requirements and provisions of the merger agreement. The range of estimated milestone payments is from zero, if no milestones are achieved, to $172.5 million if all milestones are met. We record the fair value of these obligations to pay additional milestone payments using various estimates, including probabilities of success, discount rates and amount of time until the conditions of the milestone payments are met. The $3.4 million loss on fair value remeasurement of contingent consideration relates to an increase in the estimate of the fair value of the contingent consideration primarily due to changes in discount rates and the passage of time.

Net loss: Net loss was $34.3 million, or ($0.28) per share, for the first quarter of 2017, compared to a net loss of $34.7 million, or ($0.35) per share, for the comparable period in 2016.

Financial guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2017 combined with the anticipated proceeds from future sales of our common stock under our Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2018; however, this guidance assumes we are able to and elect to pay future Kolltan contingent milestones, if any, in stock rather than cash.

Opdivo is a registered trademark of Bristol-Myers Squibb. Keytruda is a registered trademark of Merck Sharp & Dohme Corp.