ProMIS Neurosciences Announces Fiscal Year 2017 Annual Results

On March 14, 2018 ProMIS Neurosciences, Inc. a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, reported its operational and financial results for the year ended December 31, 2017 (Press release, ProMIS Neurosciences, MAR 14, 2018, View Source [SID1234525140]).

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"Over the course of the past year, we have significantly advanced our lead product candidate for Alzheimer’s disease, PMN310, demonstrating its emerging best in class profile in direct head-to-head comparison with other amyloid beta-targeted antibody therapeutics", said Eugene Williams, ProMIS Executive Chairman.

ProMIS also initiated new programs to develop antibodies against novel therapeutic targets on TDP43 for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), tau protein for Alzheimer’s disease (AD), and alpha-synuclein for Parkinson’s disease (PD), representing important additional opportunities in neurodegenerative diseases.

For a narrated overview of fiscal year 2017 results and outlook for 2018, please click on the link below:

http://bit.ly/2FxBuUv

Corporate Highlights

During 2017, completed private placements providing aggregate gross proceeds of approximately $7,510,000.
Successfully completed validation of five therapeutic candidates for AD, all of which demonstrated the desired target profile of binding to soluble brain tissue extracts from AD patients without binding to plaque.
Designated PMN310 as the lead product candidate for AD and demonstrated that PMN310 displays the desired profile of selectively targeting amyloid beta oligomers in a preclinical study comparing PMN310 to other amyloid beta-directed antibodies for AD.
Successfully completed humanization of PMN310 (huPMN310) for further development as lead product candidate.
Initiated programs to identify novel therapeutic targets for AD, ALS and PD.
Filed a provisional patent application with the U. S. Patent and Trademark Office relating to a novel therapeutic target on misfolded forms of TDP43 and initiated development of antibodies selective for this target associated with toxic, aggregated forms of TDP43.
ProMIS’ sponsored research agreement with the University of British Columbia received a matching industry partnered grant from the Canadian Institute of Health Research (CIHR).
Common shares of ProMIS commenced trading on December 4, 2017 on the OTCQB Venture Market in the U. S. under the stock symbol "ARFXF".
On January 4, 2018, ProMIS announced that PMN310 shows potential for improved safety profile in direct comparison to other amyloid beta-directed antibodies. The observed lack of PMN310 binding to perivascular amyloid plaque in AD brain tissue may eliminate dose-limiting brain swelling seen with aducanumab, supporting administration of higher doses to AD patients, thereby leading to greater therapeutic potency of PMN310.
Exercises of common share warrants yield gross proceeds of $1,484,498.
Financial Results

Annual Results of Operations

The Company’s net loss for the year ended December 31, 2017 was $6,019,970, compared to a net loss of $3,454,975 year ended December 31, 2016. Included in the net loss amount for the year ended December 31, 2017 were non-cash expenses of $700,953, representing share-based compensation and amortization of an intangible asset, compared to $578,254 for the year ended December 31, 2016. The increase in the net loss for the year ended December 31, 2017 is related to the costs associated with developing the Company’s AD therapeutics program, increased contracted resources and associated costs, supporting its patent portfolio, associated general corporate expenditures and higher share-based compensation.

Research and development expenses for the year ended December 31, 2017 were $3,961,375, as compared to $1,865,507 in the year ended December 31, 2016. The increase in research and development expense for the year ended December 31, 2017 is primarily attributed to higher research program costs for the AD therapeutics program, consultants and increased contracted resources.

General and administrative expenses for the year ended December 31, 2017 were $2,061,387, as compared to $1,576,271 in the year ended December 31, 2016. The increased expenditures for 2017 reflect primarily higher share-based compensation, contracted resources and other professional fees.

Outlook

The Company’s top priority for 2018 is to focus on further differentiation of PMN310 as best in class therapy for AD and to continue to progress development of PMN310 for clinical trial initiation in 2019.

The Company will also continue to expand its program targeting TDP43 in ALS and FTD and its alpha-synuclein program for PD. ProMIS will actively seek a collaborative development partnership for both these opportunities.

Heat Biologics to Present at the B. Riley FBR Inaugural China Healthcare Investing & Partnering Symposium

On March 14, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that Dr. John Prendergast, Lead Independent Director of Heat Biologics, will present corporate highlights and positive interim data from its Phase 2 lung cancer clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb’s checkpoint inhibitor nivolumab (Opdivo) at the B. Riley FBR Inaugural China Healthcare Investing & Partnering Symposium (CHIPS) on Friday, March 16, 2018 at 10AM China Standard Time (Press release, Heat Biologics, MAR 14, 2018, View Source [SID1234524970]). The conference will be held March 15-17, 2018 at the Intercontinental Hotel in Hangzhou, China. CHIPS is focused on building cross-border relationships between Chinese and Western Healthcare investors and companies.

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Heat Biologics’ presentation will not be webcast, but a copy may be found in the Investor Relations section of the Company’s website.

Zymeworks Reports 2017 Year-End Financial Results

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.

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).