On March 12, 2019 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Guardant Health, MAR 12, 2019, View Source [SID1234534251]).

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Recent Highlights

Revenue of $32.9 million for the fourth quarter and $90.6 million for the full year of 2018, representing 64% and 82% increases, respectively, over the corresponding periods of 2017

NILE study, a head-to-head comparison of the Guardant360 assay to standard-of-care tissue testing met its primary endpoint, detecting a similar number of targetable biomarkers in NSCLC patients, which supports utilization of Guardant360 testing ahead of tissue testing

Launched the LUNAR assay to academic and biopharmaceutical researchers to support investigation of clinical applications, including for residual disease/recurrence monitoring and early detection

Announced an agreement with AstraZeneca to support the development of the Guardant360 and GuardantOMNI assays for use as companion diagnostics for Tagrisso and Imfinzi, respectively
"During 2018, we made important headway on key initiatives and are continuing to see strong adoption of our liquid biopsy platform, which has driven increased revenue of more than 80 percent over the prior year," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We believe the recent NILE readout is an important catalyst supporting a blood-first paradigm for first-line use of Guardant360 testing for treatment selection ahead of tissue testing, offering lung cancer patients improved care with a faster time to treatment."

"In addition, we are encouraged by the progress we are making with our LUNAR program and look forward to presenting pilot LUNAR data at the AACR (Free AACR Whitepaper) conference next month. As a result of these developments, we are ramping up investment to accelerate our research and development efforts toward earlier cancer detection," continued Dr. Eltoukhy.

On March 12, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that data from the Phase 2 multicenter trial evaluating ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in relapsing forms of Multiple Sclerosis (RMS) has been selected for presentation at the upcoming American Academy of Neurology (AAN) annual meeting, to be held May 4 – 10, 2019 in Philadelphia, Pennsylvania (Press release, TG Therapeutics, MAR 12, 2019, View Source [SID1234534250]). Final data from the core Phase 2 trial has been previously presented, most recently at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual meeting in Dallas, TX. In addition to highlighting the final Phase 2 data, the AAN presentation plans to include data from the open label extension (OLE), a trial made available to any patient who completed the core Phase 2 trial allowing them to continue treatment with ublituximab.

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The abstract is available online and can be accessed via the below link or on the AAN meeting website at www.aan.com.

Presentation Details:

Title:Open Label Extension (OLE) of Phase 2 Multicenter Study of Ublituximab (UTX), a Novel Glycoengineered Anti-CD20 Monoclonal Antibody (mAb) in Patients with Relapsing Forms of Multiple Sclerosis (RMS)
— Presentation Date & Time:Tuesday May 7, 2019, 5:30 PM – 6:30 PM ET
— Session Title: Poster Session P3: MS Clinical Trials and Therapeutic Research
— Presenter:Edward Fox, MD, PhD, Central Texas Neurology Consultants, Round Rock, TX
— Location:Pennsylvania Convention Center
— Abstract Number: 2055
These data support the ongoing, fully enrolled, international Phase 3 program evaluating ublituximab for the treatment of RMS. The Phase 3 trials, entitled ULTIMATE I and ULTIMATE II, are being conducted under Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) and are being led by Lawrence Steinman, MD, of Stanford University.

On March 12, 2019 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that management will participate in four investor conferences in March, including the 31st Annual ROTH Conference in Laguna Niguel, California, the Oppenheimer 29th Annual Healthcare Conference in New York City, the Oppenheimer’s Biotech Summit by the Lake at Northwestern University in Evanston, Illinois, and the ROTH Battle of NASH Thrones Spring Investor Conference in New York City (Press release, CymaBay Therapeutics, MAR 12, 2019, View Source [SID1234534243]).

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31st Annual ROTH Conference
Date: Monday, March 18
Time: 9:30am Pacific Time
Format: Panelist: Why Knowing NASH as a Generalist Can Make You Rich in 2019

Time: 12:00pm Pacific Time
Format: Fireside Chat
Webcast: View Source

Oppenheimer 29th Annual Healthcare Conference
Date: Tuesday, March 19
Time: 8:35am Eastern Time
Format: Fireside Chat
Webcast: View Source

Oppenheimer’s Biotech Summit by the Lake
Date: Wednesday, March 27
Time: 1:00pm Central Time
Format: Corporate Presentation

ROTH Battle of NASH Thrones Spring Investor Conference
Date: Thursday, March 28
Time: 8:00 am Eastern Time
Format: Panel: 12 Months of Data – 2019 Is the Year for FXR and PPAR Clinical Readouts

Time: 4:00pm Eastern Time
Format: Panel: Why MRI May Hold the Key to the Kingdom in Diagnosis and Drug Development

On March 12, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company reported that members of the Company’s research and development team will present results from a study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, which is being held March 29 to April 3 in Atlanta, Georgia (Press release, IMV, MAR 12, 2019, View Source [SID1234534242]). The new preclinical research highlights the unique features of DPX-based T cell immunotherapies.

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"The unique capabilities of our DPX-based platform and its potential to fuel novel treatment approaches continue to drive IMV’s robust research and development program"

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"The unique capabilities of our DPX-based platform and its potential to fuel novel treatment approaches continue to drive IMV’s robust research and development program," said Marianne Stanford, PhD, Vice President, Research and Development of IMV. "We are looking forward to presenting additional insights into the way our platform works, and its capacity for working with other anti-cancer agents, at this year’s AACR (Free AACR Whitepaper) annual meeting. This work supports our goal of expanding the benefits of immunotherapies to a wider range of patients and indications."

Details of IMV’s AACR (Free AACR Whitepaper) 2019 poster is as follows:

Session Category: Immunology
Abstract Number: 4989
Authors: Ava Vila-Leahey, Alecia MacKay, Genevieve Weir, Marianne Stanford

Title: T-distributed stochastic neighbor embedding (t-SNE) analysis of tumor infiltrating lymphocytes after treatment with a T cell activating therapy identifies a unique population of recruited CD8+ T cells and novel options for combination immunotherapy

Date: Wednesday Apr 3, 2019
Time: 8:00 a.m. – 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 24
Poster Board Number: 12

Meeting abstracts are available at AACR (Free AACR Whitepaper)’s website.

On March 12, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage company developing novel epigenetic therapies, reported the closing of its two concurrent underwritten public offerings of 11,500,000 shares of its common stock and 350,000 shares of its non-voting Series A Convertible Preferred Stock, which includes the full exercise by the underwriters of their separate options in each of the respective offerings to purchase additional shares at the public offering price (Press release, Epizyme, MAR 12, 2019, View Source [SID1234534241]). The public offering price of each share of common stock was $11.50 and the public offering price of each share of Series A stock was $115.00.

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The aggregate gross proceeds to Epizyme from the offerings, before deducting underwriting discounts and offering expenses, are $172.50 million.

Epizyme anticipates using the net proceeds from these offerings, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of Epizyme’s ongoing and planned clinical trials of tazemetostat, the costs of regulatory activities related to tazemetostat, including associated milestone payments, and the costs associated with the commercial launch of tazemetostat for epithelioid sarcoma and follicular lymphoma, if approved; expansion of tazemetostat into additional treatment lines, combinations and indications; to fund research and development costs to identify and develop other product candidates, including EZM8266 for sickle cell disease; and for working capital and other general corporate purposes.

Jefferies, Citigroup and Cowen acted as joint book-running managers for the proposed offerings. Wedbush PacGrow acted as lead manager and H.C. Wainwright & Co. acted as co-manager.

A shelf registration statement relating to the shares of common stock and the Series A stock offered in the public offerings was filed with the Securities and Exchange Commission ("SEC") on April 5, 2018 and was automatically effective upon filing. The offerings of common stock and Series A stock were made only by means of written prospectuses and prospectus supplements that each form a part of the registration statement. Prospectus supplements relating to and describing the terms of each offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the prospectus supplements and the accompanying prospectuses relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by phone at 800-831-9146; or Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by telephone at (631) 274-2806 or by fax at (631) 254-7140.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.