Titan Pharmaceuticals To Present At The First Annual BioTuesdays Pre-JPM Virtual Conference

On December 3, 2019 Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) reported that management will present an update on the Company’s business at the first annual BioTuesdays Pre-JPM Virtual Conference on Tuesday, December 10, 2019 at 3:00 p.m. EST / 12:00 p.m. PST (Press release, Titan Pharmaceuticals, DEC 3, 2019, View Source [SID1234551895]).

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The presentation will be broadcast live and archived on Titan’s website at www.titanpharm.com/news/events.

Entry into a Material Definitive Agreement

On December 3, 2019 (the "Closing Date"), Veracyte, Inc. (the "Company") reported that it has entered into a License and Asset Purchase Agreement (the "LAPA") with NanoString, Inc. ("NanoString"), pursuant to which the Company (the "Transaction") (i) obtained an exclusive worldwide license to NanoString’s nCounter FLEX Analysis System (the "FLEX System") for in vitro diagnostic use and for the development and commercialization of in vitro diagnostic tests, including in vitro diagnostic devices (IVDs) or laboratory developed tests (LDTs), for use on the FLEX System (collectively, the "License") and (ii) acquired certain assets, including NanoString’s rights with respect to the Prosigna Breast Cancer Prognostic Gene Signature Assay ("Prosigna"), the LymphMark Lymphoma Subtyping Test ("LymphMark") and the assay software modules that operate together with the FLEX System (Filing, 8-K, Veracyte, DEC 3, 2019, View Source [SID1234551880]). In connection with the Transaction, the Company will assume certain liabilities associated with the assets purchased under the LAPA, including ongoing third-party royalty obligations related to Prosigna and LymphMark. As part of the Transaction, the Company will also offer certain employees of NanoString employment. In connection with entering into the LAPA, the Company and NanoString also entered into various service and supply agreements relating to the manufacture and supply of Prosigna, LymphMark, and other in-vitro diagnostic tests that may be developed by or on behalf of the Company for use on the FLEX System and for the manufacture and supply of the FLEX System.

As consideration under the LAPA, the Company will pay NanoString $40,000,000 in cash. NanoString is also entitled to receive 376,732 shares of the Company’s common stock (the "Equity Consideration"), which shares represent a value of approximately $10,000,000 based on the average closing price of the Company’s common stock for the ten consecutive trading days ending on the third trading day prior to the Closing Date. The Company is required under the LAPA to register the Equity Consideration for resale within 90 days of the Closing Date as set forth in the registration rights schedule to the LAPA (the "Registration Rights Schedule").

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Pursuant to the terms of the LAPA, NanoString may not sell the Equity Consideration for the first 90 days following the Closing Date. Thereafter, NanoString may, subject to limited exceptions, not sell Equity Consideration representing more than 10% of the average daily trading volume of the Company’s common stock for the 30-day period preceding any such sale.

Pursuant to the LAPA, NanoString is also eligible to receive three additional payments, based upon the achievement of certain commercialization milestones, totaling $10,000,000 in the aggregate (the "Milestone Payments"). The individual Milestone Payments of $3,500,000, $3,500,000 and $3,000,000 will be due, respectively, upon the Company’s commercial launch of the first, second and third diagnostic test for use on the FLEX System, other than Prosigna or LymphMark, in each case as measured by the processing of the first commercial patient sample.

The foregoing summaries of the LAPA and Registration Rights Schedule are not complete and are qualified in their entirety by reference to the LAPA and Registration Rights Schedule, copies of which are filed as Exhibits 2.1 and 4.1 to this Current Report on Form 8-K and are incorporated herein by reference. The LAPA contains customary representations and warranties, covenants and indemnities. The representations, warranties and covenants contained in the LAPA were made only for the purposes of the LAPA, were made as of specific dates, and were made solely for the benefit of the parties to the LAPA, and may not have been intended to be statements of fact but, rather, as a method of allocating risk and governing the contractual rights and relationships among the parties. The assertions embodied in those representations and warranties may be subject to important qualifications and limitations agreed to by the parties in connection with negotiating their respective terms. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to the Company’s stockholders. For the foregoing reasons, none of the Company’s stockholders or any other person should rely on such representations and warranties, or any characterizations thereof, as statements of factual information at the time they were made or otherwise.

Piramal Pharma Solutions Announces Collaboration With BerGenBio on the Development of FDA Fast Track Designated Leukemia Treatment

On December 3, 2019 Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), reported that the company will be partnering with BerGenBio ASA (OSE: BGBIO) on the development of bemcentinib for the treatment of elderly patients with relapsed Acute Myeloid Leukemia (AML) (Press release, Piramal, DEC 3, 2019, View Source [SID1234551896]). Bemcentinib was recently designated as a Fast Track drug by the U.S. Food and Drug Administration (FDA), as there are currently no marketed drugs specifically approved for relapsed AML patients, representing a significant unmet medical need.

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Peter DeYoung, CEO, Piramal Pharma Solutions, stated, "BerGenBio’s decision to partner with us is a validation of our integrated business model. The breadth and scale of our assets and our expertise as a leading CDMO allow us to customize services according to their needs and deliver solutions that benefit the patients."

Richard Godfrey, Chief Executive Officer of BerGenBio, stated that "Outsourcing of development and manufacturing services is a requirement for us, and we were rigorous in our due diligence of potential partners. Piramal Pharma Solutions’ capabilities – especially the Xcelerate Integrated Solutions platform – represent an ideal solution for BerGenBio."

To accelerate the timelines required for Fast Track development, PPS will be developing the drug leveraging its Xcelerate Integrated Solutions platform that delivers speed, flexibility and versatility to the drug development process. The Xcelerate platform, which addresses the industry’s growing need for preferred partner relationships, has been successfully applied to more than eighty programs.

Xcelerate Integrated Solutions takes advantage of the extensive PPS network of drug discovery and development capabilities located across its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all managed by a single point of contact who expedites the exchange of information and accelerates timelines.

The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediates sourced from India, pilot process development and API validation in North America and formulation development in Europe. As part of the partnership agreement, PPS is also expected to provide commercial manufacturing of the final drug product.

Genomic Testing Cooperative to Present at American Society of Hematology Annual Meeting 2019

On December 3, 2019 Genomic Testing Cooperative, LCA (GTC) reported that they will be presenting data on their proprietary AI-based algorithms and RNA and DNA testing at the American Association of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Press release, Genomic Testing Cooperative, DEC 3, 2019, View Source [SID1234553223]). In collaboration with multiple academic centers, GTC developed new approaches for the classification of diseases and prediction of response to combination therapy.

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Dr. Maher Albitar, GTC Chief Executive Officer and Chief Medical Officer, stated "Cancer is complex disease and requires complex biomarkers for predicting its behavior. RNA Sequencing provides a wealth of information that can be used for predicting clinical course and response to combination therapy. RNA sequencing data, when combined with mathematical algorithms, can provide reliable means to manage and treat cancer. GTC is committed to be the leader in innovation in developing molecular biomarkers to help physicians select the proper combination therapy for their patients."

Highlights of GTC presentations include:
-Targeted next generation sequencing (NGS) of RNA is reliable and practical for routine clinical testing.

-RNA sequencing data when used with AI or Bayesian statistics can provide powerful means for predicting clinical behavior and response to combination therapy

-Testing for mutations using RNA may provide a new paradigm for better characterizing and monitoring of cancers

-Liquid biopsy provides important clinical information in patients with acute myeloid leukemia.

The following is a list of studies that will be presented by GTC and its collaborators at ASH (Free ASH Whitepaper):
1) 2891-Title: "Cell of Origin Classification of DLBCL Using Targeted NGS Expression Profiling and Deep Learning"

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

2) 2730-Title: "Higher Stability of Mutant IDH1/2 mRNA As Compared to Wild-Type mRNA in Patients with Acute Myeloid Leukemia"

Collaborators: Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

3) 1314-Title: "Expression Profiling of mRNA By Next Generation Sequencing and the Development of Algorithm for Predicting Response in Acute Myeloid Leukemia"

Collaborators: Department of Computer Science, Georgia Southern University, Savannah, Georgia;
Departments of Leukemia, Stem Cell Transplantation, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX

4) 1499-Title: Higher Stability of Mutant mRNA As Compared to Wild-Type mRNA in Diffuse Large B-Cell Lymphoma

Collaborators: University of Texas MD Anderson Cancer Center, Houston, TX; University of California, Irvine, CA; University Hospital Basel, Basel, Switzerland; University of Verona, Verona, Italy; Columbia University Medical Center, New York, NY; Aalborg University Hospital, Aalborg, Denmark; Well Cornell Medical College, New York, NY; Cleveland Clinic, Cleveland, OH; San Raffaele Scientific Institute, Milano, Italy; San Raffaele Hospital, Milan, Italy; Odense University Hospital, Odense, Denmark; Instituto de Investigación Marqués De Valdecilla, Santander, Spain; University Hospital Nijmegen, Nijmegen, NLD; Houston Methodist Hospital, Houston, TX; Lerner Research Institute, Cleveland Clinic, Cleveland, OH.

5) 2592-Title: Sequencing of Circulating Cell-Free DNA in Patients with AML Detects Clinically Significant Mutations Not Detected in Bone Marrow: The Role for Complementary Peripheral Blood and Bone Marrow Genomic Analysis

Collaborators: Departments of Leukemia, Genomic, and Hematopathology, UT MD Anderson Cancer Center, Houston, TX.

ImmuPharma to present at Biotech Showcase™ 2020 in San Francisco

On December 3, 2019 ImmuPharma PLC (LSE:IMM), a specialist drug discovery and development company, is reported that it will be presenting at the Biotech Showcase 2020, to be held between 13–15 January 2020, at the Hilton, San Francisco Union Square (Press release, ImmuPharma, DEC 3, 2019, View Source [SID1234551863]).

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Dr Tim Franklin, Commercial Advisor to ImmuPharma, will be presenting to conference attendees on 14th January 2020 at 10:30am (EST) in room Yosemite C (Ballroom Level). If you are attending the event and would like to meet with Dr Franklin for a one to one meeting, please contact Lisa Baderoon, Head of Investor Relations, who will be able to arrange a meeting: [email protected].