On March 14, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported financial results for the year ended December 31, 2017 (Press release, Zymeworks, MAR 14, 2018, View Source [SID1234524777]).

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"2017 was marked by a number of key corporate successes," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We continued to generate promising clinical results for ZW25, added a sixth global pharmaceutical partner, and saw important progress in our partners’ programs as they advanced compounds utilizing our technology towards the clinic."

2017 Business Highlights and Recent Developments

Expanded Clinical Dataset for ZW25
The Company reported results from the dose-escalation portion of its ongoing Phase 1 clinical trial, showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers. Zymeworks has increased the number of clinical trial sites in the United States and is in the process of activating multiple sites across Canada.
Established New Corporate Partnership
Zymeworks provided a license to Janssen to develop up to six bispecific antibodies in a transaction potentially worth US$1.45 billion including a US$50 million upfront payment, milestones, and tiered royalties on product sales.
Partners’ Programs Progress Towards the Clinic
Two long-term partners (Lilly and Merck) have selected lead Azymetric bispecific candidates for advancement towards the clinic, and Daiichi Sankyo’s program achieved a significant research milestone resulting in a payment to Zymeworks.
Dr. Tehrani noted, "Looking ahead, we plan to build on the momentum established last year as we create additional value throughout our business. We anticipate achieving the following milestones: complete enrollment in our Phase 1 study and report additional data for ZW25; file an Investigational New Drug (IND) Application for our second clinical compound, ZW49; present preclinical data on our other product candidates; and expand our partnering activities."

Financial Results for the Year Ended December 31, 2017

Revenue in 2017 was $51.8 million as compared to $11.0 million in 2016. The increase of $40.8 million was primarily due to the recognition of a $50.0 million upfront fee received from Janssen and a $1.0 million milestone payment from Daiichi Sankyo.

For the year ended December 31, 2017, research and development expenditures were $41.7 million as compared to $36.8 million in the prior year. The increase was primarily due to clinical costs for ZW25 and development costs for ZW49. General and administrative expenses were $18.6 million in 2017 and $12.6 million in 2016. The change between the periods was primarily due to an increase in compensation costs, professional fees, and other administrative expenses.

The net loss for the year ended December 31, 2017, decreased to $10.4 million as compared to $33.8 million in 2016, primarily due to increased revenue offsetting research and development expenses as previously noted. Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities.

As of December 31, 2017, Zymeworks had $87.8 million in cash and cash equivalents and short-term investments. Zymeworks expects to continue receiving revenue from its existing and future corporate collaborations, including technology access fees, research and development fees for services rendered and milestone-based payments. However, its ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

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.

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).

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.

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.