Verastem Updates Presentation Time for Oppenheimer & Co. Healthcare Conference

On March 14, 2018 Verastem, Inc. (NASDAQ:VSTM), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that the Company will present at the 28th Annual Oppenheimer & Co. Healthcare Conference on Tuesday, March 20, 2018 at 8:00am in New York City, NY, USA (Press release, Verastem, MAR 14, 2018, View Source;p=RssLanding&cat=news&id=2338094 [SID1234524776]). Verastem’s presentation was originally scheduled for 11:30am but was subsequently moved to 8:00am.

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A live webcast of the presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

TESARO Announces Data Presentations at the 2018 American Association for Cancer Research Annual Meeting

On March 14, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that data for ZEJULA, TSR-042 (anti-PD-1 antibody) and the company’s immuno-oncology portfolio will be presented at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14-18, 2018 in Chicago (Press release, TESARO, MAR 14, 2018, View Source [SID1234524775]).

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"This year’s AACR (Free AACR Whitepaper) annual meeting will mark the first presentation of initial data from the GARNET trial of TSR-042, our anti-PD-1 antibody, in patients with MSI-high endometrial cancer or non-small cell lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "TSR-042 provides a strategic advantage for TESARO in further developing niraparib and our immuno-oncology product candidates, and we expect to complete enrollment in the MSI-high registration trial at the end of this year. The breadth of our IO portfolio, which also includes antibodies targeting TIM-3 and LAG-3, enables TESARO to evaluate novel combination approaches with a goal of providing transformative therapies for people living with cancer."

Please plan to visit TESARO at Booth #1645 for information on the expanded development program for ZEJULA, TSR-042 and our broader immuno-oncology portfolio.

Poster Information (all times local):

Immuno-oncology

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Preliminary safety, efficacy and PK/PD characterization from GARNET, a phase I clinical trial of the anti-PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced NSCLC or MSI-H endometrial cancer
Poster Session, Abstract: CT053, Location: Exhibit Hall A, Poster Section 42, Poster Board 6

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Checkpoint inhibitor signatures across endometrial cancer histologies
Poster Session, Abstract: 1687, Location: Exhibit Hall A, Poster Section 31, Poster Board 12

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Simultaneous measurement and significance of PD-1, LAG-3 and TIM-3 expression in human solid tumors
Poster Session, Abstract: 1681, Location: Exhibit Hall A, Poster Section 31, Poster Board 6

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Investigation of the expression profile and functional role of PD-1, TIM-3 and LAG-3 in human tumors
Poster Session, Abstract: 2722, Location: Exhibit Hall A, Poster Section 32, Poster Board 14

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Characterization of tumor growth and immune microenvironment in humanized NOG-EXL mice implanted with A549, MDA-MB-436 and A375 cells
Poster Session, Abstract: 5690, Location: Exhibit Hall A, Poster Section 31, Poster Board 26

ZEJULA (niraparib)

Monday, April 16, 2018, 1:00 PM to 5:00 PM
Efficacy and pharmacokinetics of niraparib in BRCA-mutant and wild-type intracranial triple negative breast cancer murine models
Poster Session, Abstract: 2813, Location: Exhibit Hall A, Poster Section 37, Poster Board 3

Monday, April 16, 2018, 8:00 AM to 12:00 PM
Evaluation of niraparib in combination with anti-PD1/anti-PD-L1 in preclinical models
Poster Session, Abstract: 1724, Location: Exhibit Hall A, Poster Section 32, Poster Board 19

Wednesday, April 18, 2018, 8:00 AM to 12:00 PM
Enhanced anti-tumor effects of selinexor and niraparib in preclinical models of ovarian cancer
Poster Session, Abstract: 5826, Location: Exhibit Hall A, Poster Section 37, Poster Board 22

Niraparib is marketed in the United States and Europe under trade name ZEJULA.

About ZEJULA (niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.

About TSR-042
TSR-042 is a monoclonal antibody targeting PD-1 and was developed as part of the collaboration between TESARO and AnaptysBio, Inc. This collaboration was initiated in March of 2014, and is focused on the development of monospecific antibody drugs targeting PD-1, TIM-3 (TSR-022), and LAG-3 (TSR-033), in addition to a bi-specific antibody drug candidate targeting PD-1/LAG-3 (TSR-075).

Quanterix Corporation Releases Operating Results for Fourth Quarter and Fiscal Year 2017

On March 14, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the fourth quarter and full year of 2017 (Press release, Quanterix, MAR 14, 2018, View Source [SID1234524774]). Revenues for full year 2017 of $22.9M were at the high end of the range of $22.5-$22.9M, which was previously announced in January 2018.

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"2017 was an important year for Quanterix, and I am pleased to report progress on a number of pivotal focus areas,"said Chief Executive Officer, President and Chairman, Kevin Hrusovsky. "In our first quarter as a public company, we continued to grow revenues, scale the company for future success and make inroads launching digital biomarker technologies into neurology, oncology and infectious disease application areas."

Fourth Quarter Financial Highlights

Key financial results for the fourth quarter are shown below:

·Q4 revenue of $6.6M versus prior year Q4 of $6.7M, a decrease of 1%. Q4 2016 includes $1.8M in non-recurring revenue recognized in connection with a license; excluding that the revenue growth was 35%.

Q4 product revenue totaled $4.1M versus prior year of $3.2M; Consumables drove this performance. Product revenue included the sale of five of the newly launched SR-X benchtop reader. This launch was more than a quarter ahead of schedule.

·Q4 Service and Other Revenue totaled $2.3M versus prior year of $1.7M, an increase of 34%.

·Strong liquidity position at year-end with $79.7M of cash and $9.4M of debt.

Successfully closed its initial public offering of 4,916,480 shares of common stock at a public offering price of $15.00 per share, and received $73.7M in gross proceeds from the offering, prior to deducting underwriting discounts and commissions, and offering expenses payable by the company. The shares began trading on The NASDAQ Global Market on December 7, 2017 under the ticker symbol "QTRX."

Expanded market opportunity through the launch of the new SR-X Ultra-Sensitive Biomarker Detection System, opening the door for researchers to access ultra-sensitive protein and nucleic acid detection capabilities in a more compact and affordable system. The SR-X was made commercially available in December 2017 and Quanterix received 16 orders for the new system in Q4, with limited marketing support behind the new launch.

2017 and Recent Business Highlights

Full year 2017 revenue of $22.9M, the high end of the previously provided guidance of $22.5-22.9M, versus full year 2016 revenue of $17.6M, an increase of 30% year-over-year; excluding the 2016 non-recurring revenue recognized in connection with a license, revenue growth was 45%.

Impressive full year revenue performance in consumables (70% increase) and Accelerator (57% increase); Accelerator also carried forward significant backlog into 2018.

Reinforced leadership position in the market through presentations from Kevin Hrusovsky, Chief Executive Officer, President and Chairman, at The Leerink Partners 7th Annual Global Healthcare Conference, The 36th Annual J.P. Morgan Healthcare Conference, Innovate

Conference 2017, World Medical Innovation Forum, Second Annual Brain Trust: Pathways to Innovation, 2nd Annual Powering Precision Health Summit, and participating in the Fourth and Fifth Annual Super Bowl Brain Health Summits.

Expanded the Second Annual Powering Precision Health Summit across Neurology, Oncology and Infectious Disease application areas. The summit was impactful with over 50 presentations from speakers credited with over 6000 peer reviewed publications. The conference attracted over 500 attendees from around the world, and helped to underscore the importance of Quanterix’ technologies toward enabling personalized medicine and precision health.

Expanded multiplexing immunoassay menu and accelerated entry into pharmaceutical services with a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory through the January 2018 acquisition of Aushon BioSystems, an innovator in protein detection solutions. The Company now has access to the services of the Laboratory Director of Aushon’s CLIA certified laboratory.

Strengthened its management team with the recent appointments of Dr. Dawn Mattoon as SVP of Strategic Marketing and Assay Technologies, who will lead marketing efforts for Quanterix and oversee assay development and kit manufacturing, two areas of critical importance to Quanterix’ rapidly growing customer base; and Yvan Sergeant as VP of European Commercial Operations, who will be responsible for expanding Quanterix’ business operations in Europe, and help in the establishment of a European-based Accelerator lab. The Company also expanded its relationship with neurology industry leader, Dr. Andreas Jeromin, who will serve as Scientific and Medical Advisor.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 14, 2018, at 4:30pm EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following password: 5079049.

NewLink Genetics Announces Presentation of Abstracts at AACR Annual Meeting

On March 14, 2018 NewLink Genetics Corporation (NASDAQ: NLNK) reported that two abstracts pertaining to the company’s indoximod program will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting in Chicago (Press release, NewLink Genetics, MAR 14, 2018, View Source [SID1234524773]).

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Clinical Trials Plenary Session: Abstract 10973 – Front-line therapy of DIPG using the IDO pathway inhibitor indoximod in combination with radiation and chemotherapy, to be presented during the "Multimodality Immuno-oncology Approaches" session, Sunday, April 15, 2018, 12:45 PM – 2:45 PM CT

Poster Session: Abstract 3753 – Indoximod modulates AhR-driven transcription of genes that control immune function, to be presented during poster session PO.IM02.07, April 17, 2018, 8:00 AM – 12:00 PM CT

The complete text of Clinical Plenary Session abstracts that have not been selected for the press program will be posted to the AACR (Free AACR Whitepaper) website on Friday, April 13. The text of clinical trials abstracts that have been selected for inclusion in the press program will not be posted online until the date and time of presentation.
"We are pleased to have been chosen to present these abstracts at the upcoming AACR (Free AACR Whitepaper) meeting," said Charles J. Link, Jr, MD, Chairman, CEO and Chief Scientific Officer. "Encouraging early clinical data of indoximod plus radiation for pediatric patients with DIPG, a rare and lethal form of brain cancer, will be presented. In addition, our data further clarifying indoximod’s differentiated mechanism of action will also be presented."
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.

NantHealth Reports 2017 Fourth-Quarter and Full-Year Financial Results

On March 14, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its fourth quarter and full year ended December 31, 2017 (Press release, NantHealth, MAR 14, 2018, View Source;p=RssLanding&cat=news&id=2338113 [SID1234524772]).

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In August 2017, NantHealth sold its provider/patient engagement assets to Allscripts to focus on core competencies and accelerate the plan to achieve profitability. As a result, the company has classified the current and prior period operating results of its provider/patient engagement business as discontinued operations. All results presented below represent the company’s continuing operations.

GPS Cancer – Highlights

Test Growth: The company reported 606 GPS Commercial Tests were ordered in Q4, up from 547 in Q3.
New National GPS Cancer Payer: In Q1 2018, the company signed a new GPS Cancer reimbursement contract with a large, national healthcare IT company.
New Lab Services Arrangement: In Q1 2018, the company signed a laboratory services agreement with a 20+ facility hospital system for the availability of GPS Cancer testing to its patient community.
Expanded International Adoption: In Q1 2018, the company signed a strategic reseller agreement with a partner in the United Kingdom for the provision of molecular analysis services for clinical studies and other research initiatives.
FDA Submission: In Q1 2018, NantHealth submitted a 510K premarket notification application to the FDA for tumor/normal DNA sequencing.
Company to Provide GPS Cancer Molecular Analysis to the University of California San Francisco (UCSF) to Support Research Initiative Focused on Metastatic Breast Cancer: This study will allow UCSF researchers to utilize advancements made in molecular technology to examine the potential clinical feasibility of molecular profiling, including gene mutations and gene expression in the context of patient care. The biopsy materials collected will also allow researchers to examine immune markers within the tumor architecture. Results of the clinical study to be presented at major medical conferences.
"We continue to make excellent progress on a number of operational fronts," said Patrick Soon-Shiong, M.D., Chief Executive Officer and Chairman of NantHealth. "The number of ordered GPS Commercial Tests continued to grow in our fourth quarter from the previous quarter and February 2018 was the largest month of orders in the company’s history. Moreover, we have entered into a number of contracts in the first quarter of 2018, including a reimbursement contract with a new, national GPS Cancer Payer, a laboratory services agreement with a large, multi-facility hospital system and a strategic reseller agreement with a partner in the United Kingdom. We also recently completed the submission of a 510K premarket notification application to the FDA for tumor/normal DNA sequencing."

Software and Services Highlights:

Payer Engagement:
In Q4 2017, the company signed a three year NaviNet renewal contract with a total contract value of more than $1.2 million and also went live with one of its largest customers for its new Document Exchange solution.
In Q1 2018, the company signed another NaviNet renewal contract with a total contract value of approximately $17 million.
Clinical Decision Support: In Q4 2017, the company signed an expanded services contract with an existing, national insurance carrier customer, with the potential to extend the availability of the Eviti solution to an additional 2.4 million lives.
Connected Care:
In Q4 2017, the company signed a device connectivity license contract extension with an existing customer, with the potential to expand its solution to additional facilities within the customer’s 74 hospital system.
The company’s pipeline for device connectivity sales continues to progress, with numerous international opportunities developing through its strategic resellers in Europe and Asia.
The company presented "The Future of Device Connectivity Across the Continuum of Care" at the Healthcare Information & Management Systems Society (HIMSS) Annual Conference & Exhibition 2018.
"We reported a strong fourth quarter with revenues increasing on a reduced cost base. Importantly, our SaaS business continues to grow and generate healthy gross margins," said Ron Louks, Chief Operating Officer of NantHealth. "We’ve had a remarkable turnaround in our quarterly operating results. We are proud of what our organization has been able to accomplish over the second half of 2017 and look forward to continuing this momentum in 2018."

Business and Financial Highlights

For the 2017 fourth quarter, total net revenue increased 25% to $22.3 million from $17.8 million in 2016 fourth quarter. Gross profit was $13.4 million, or 60% of total net revenue, compared with $7.0 million, or 39% of total net revenue, for the prior-year fourth quarter. Selling, general and administrative (SG&A) expenses were $20.8 compared with $16.4 million. Research and development (R&D) expenses decreased to $8.8 million from $10.8 million. Net loss from continuing operations, net of tax, significantly narrowed to $22.6 million, or $0.21 per share, from $48.4 million, or $0.40 per share for the 2016 fourth quarter. Income from discontinued operations, net of tax, was $0.9 million, or $0.01 per diluted share, versus loss from discontinued operations, net of tax, $11.5 million, or $0.09 per share, for the prior-year fourth quarter. Net loss was $21.6 million, or $0.20 per share, compared with $60.0 million, or $0.49 per share, for 2016 fourth quarter.

Financial results for the 2017 fourth quarter included approximately $4.0 million loss from related party equity method investment, $0.7 million of acquisition related sales incentive, $1.2 million of net non-cash expense related to convertible notes, $2.2 million of intangible amortization and $8.6 million of stock-based compensation expense, totaling $0.16 per share. On a non-GAAP basis, adjusted net loss from continuing operations was $7.8 million, or $0.07 per share, for the 2017 fourth quarter, compared with $14.4 million, or $0.12 per share, for the 2016 fourth quarter.

For the 2017 full year, total net revenue increased 8% to $86.7 million from $80.4 million in 2016. Gross profit rose to $45.2 million, or 52% of total net revenue, compared with $36.3 million, or 45% of total net revenue, for the prior year. SG&A expenses were $75.0 compared with $105.3 million. R&D expenses decreased to $33.9 million from $47.3 million. Net loss from continuing operations, net of tax, was $131.4 million, or $1.12 per share, from $140.5 million, or $1.30 per share for 2016. Loss from discontinued operations, net of tax, was $43.8 million, or $0.37 per share, compared with $43.6 million, or $0.39 per share, for the prior year. Net loss was $175.2 million, or $1.49 per share, compared with $184.1 million, or $1.69 per share, for 2016.

Financial results for the 2017 full year included approximately $50.3 million loss from related party equity method investment including impairment loss, $2.4 million for corporate restructuring, $2.7 million of acquisition related sales incentive, $4.4 million of net non-cash expense related to convertible notes, $9.4 million of intangible amortization and $8.1 million of stock-based compensation expense, totaling $0.66 per share. On a non-GAAP basis, adjusted net loss from continuing operations was $55.3 million, or $0.47 per share, for the 2017 full year quarter, compared with $58.2 million, or $0.50 per share, for the 2016 full year.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the fourth quarter and full year ended December 31, 2017. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 2987414. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.