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.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

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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Zymeworks Advances Clinical Candidate Incorporating Technology from Kairos Acquisition

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.

MEI Pharma To Present at Two Upcoming Investor Conferences

On March 14, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, reported that it will webcast a business overview and update by Daniel P. Gold, Ph.D., president and chief executive officer, at each of the following upcoming healthcare conferences (Press release, MEI Pharma, MAR 14, 2018, View Source [SID1234524761]):

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The Oppenheimer 28th Annual Healthcare Conference at 10:55 a.m. ET on Wednesday, March 21, 2018 in New York, NY.
The 17th Annual Needham Healthcare Conference at 4:30 p.m. ET on Tuesday, March 27, 2018 in New York, NY.

A live audio webcast of each event can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source, or by following the links below in your web browser.

Oppenheimer 28th Annual Healthcare Conference: https://veracast.com/webcasts/opco/healthcare2018/07207656259.cfm
17th Annual Needham Healthcare Conference: View Source

An archived replay of each webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.

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.