On March 15, 2018 ProMIS Neurosciences, Inc., a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, reported that it will participate in two upcoming investor conferences (Press release, ProMIS Neurosciences, MAR 15, 2018, View Source [SID1234525136]):

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Eugene Williams, Executive Chairman, will present at the Sachs BioCapital USA Forum at the New York Academy of Sciences, 250 Greenwich St, New York, NY, on Wednesday, March 21st, at 2 PM, Eastern Daylight Time (EDT). Prior to the presentation, Mr. Williams will participate in a panel discussion entitled: ‘Renewed Approaches for Neuroscience’. The panel discussion will be held at 11:45 AM, EDT.
Mr. Williams will also present at the Wall Street Investor Forum 26th Annual Growth Conference at the University Club of NYC, 1 W 54th St, New York, on Thursday, March 22nd, at 9:35 AM, EDT.

AmpliPhi Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AmpliPhi Biosciences, 2018, MAR 14, 2018, View Source [SID1234524796]).

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On March 14, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small-molecule drugs that address cancer, liver disease and inflammatory diseases, reported that Dr. Pnina Fishman, Can-Fite’s Chief Executive Officer, will present at the 2nd Annual H.C. Wainwright NASH Investor Conference on March 19 at 5:20 p.m. ET in New York City (Press release, Can-Fite BioPharma, MAR 14, 2018, View Source [SID1234524757]). The presentation will focus on its drug candidate Namodenoson (CF102), A3 adenosine receptor (A3AR), currently in a Phase II trial for the treatment of NAFLD, and non-alcoholic steatohepatitis (NASH).

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Recent Positive Safety Data on Namodenoson

Can-Fite’s current Phase II study is being conducted in three Israeli sites, including Hadassah Medical Center, Jerusalem, and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The Company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable safety profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

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 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that ZW49 is the first product candidate selected for clinical development utilizing the ZymeLink antibody-drug conjugate (ADC) platform, acquired as part of the Company’s 2016 acquisition of Kairos Therapeutics (Press release, Zymeworks, MAR 14, 2018, View Source [SID1234529108]). ZW49 was developed by leveraging ZymeLink in combination with Zymeworks’ flagship Azymetric bispecific platform. The Company expects to file an Investigational New Drug (IND) application this year in order to begin clinical trials with ZW49 for patients with HER2-expressing cancers.

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ZW49 is a novel bispecific ADC targeting two distinct domains of the HER2 receptor resulting in enhanced internalization and delivery of its proprietary ZymeLink cytotoxic payload. ADCs incorporating ZymeLink have demonstrated a greater therapeutic window (range of doses that are both efficacious and tolerable) in preclinical testing than those incorporating the commonly used ADC payloads DM1 or MMAE. As a result, ZW49 exhibited superior activity when assessed against other approved HER2-targeted therapies and Zymeworks’ previous internal ADC candidate, ZW33. Consequently, the Company will advance ZW49 in lieu of ZW33. Preclinical data on ZW49 and more generally on the ZymeLink ADC platform will be presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to be held April 2018 in Chicago. Abstracts for these preclinical data were published today.

"The data generated by ZW49 clearly supported its designation as our second product candidate for clinical evaluation," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "With the addition of the complementary ZymeLink technology, including proprietary linkers and payloads, we have been able to further leverage the power of our Azymetric platform to create a differentiated molecule that we believe has the potential for best-in-class activity and tolerability."

Zymeworks, whose protein engineering expertise and resulting therapeutic platforms have resulted in a network of global biopharmaceutical partners, is keenly focused on developing its own portfolio of product candidates. Its lead compound, ZW25, is currently being assessed in an adaptive Phase 1 clinical trial and has shown promising single-agent anti-tumor activity in patients with heavily pretreated HER2-expressing cancers that have progressed after standard of care. Zymeworks continues to accelerate the development of ZW25 and is opening several new clinical sites across North America in 2018.

"With the advancement of ZW49, we now have a portfolio of agents with the potential to address the full spectrum of patients with HER2-expressing cancers," said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. "This includes those underserved patients whose tumors express lower levels of HER2 and are ineligible for treatment with HER2-targeted therapies, such as trastuzumab, pertuzumab, and T-DM1."

About ADCs

Antibody-drug conjugates are a class of anti-cancer therapies intended to precisely target tumor cells in order to avoid the significant toxicities routinely associated with cancer treatments while simultaneously improving their efficacy. An ADC is an antibody connected, or conjugated, to a small molecule drug. It has three critical components: the antibody for targeting of specific cells, the cytotoxin (or payload) being delivered to induce cancer cell death, and the linker, which connects the two components together.

About ZW49

ZW49 is a biparatopic (a bispecific antibody that can simultaneously bind two non-overlapping epitopes on a single target) anti-HER2 ADC based on the same framework as ZW25 but armed with the company’s proprietary ZymeLink cytotoxic (potent cancer-cell killing) payload. ZW49 may mediate its therapeutic effect through a combination of mechanisms, including: increased HER2 receptor-antibody clustering and internalization leading to toxin-mediated cytotoxicity; dual HER2 signal blockade; increased binding and removal of HER2 protein from the cell surface; and potent effector function.