Oragenics Inc. to Present at the LD Micro 12th Annual Main Event on December 10, 2019

On December 3, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that Alan Joslyn, Ph.D., president and CEO of Oragenics, Inc. will be a featured presenter at the LD Micro Main Event on Tuesday, December 10, 2019 at 1:00 PM Pacific Time at the Luxe Sunset Boulevard Hotel in Los Angeles, CA (Press release, Oragenics, DEC 3, 2019, View Source [SID1234551884]).

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Dr. Joslyn will provide an overview of the company’s business model and growth strategy and will be available for one-on-one meetings.

For those interested in attending or for registered attendees who wish to request meetings, please contact David Scher at [email protected] or visit www.ldmicro.com for more information.

Oncternal Therapeutics to Present Cirmtuzumab Clinical Data Updates at 2019 ASH Annual Meeting and San Antonio Breast Cancer Symposium

On December 3, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that clinical data updates for cirmtuzumab, its investigational anti-ROR1 monoclonal antibody, will be presented at upcoming medical conferences (Press release, Oncternal Therapeutics, DEC 3, 2019, View Source [SID1234551883]).

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Interim data from the ongoing Phase 1/2 clinical study of cirmtuzumab in combination with ibrutinib in patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting that will be held December 7-10, 2019, in Orlando, FL.

Abstract: Cirmtuzumab, a ROR1 Targeted mAb, Reverses Cancer Stemness, and Its Combination with Ibrutinib Is Safe and Effective: Planned Analysis of the CIRLL Phase 1/2 Trial for CLL and MCL (abstract #1755)
Session Name: 642. CLL: Therapy, excluding Transplantation: Poster I
Session Date: Saturday, December 7, 2019
Session Time: 5:30 PM – 7:30 PM
Location: Hall B, Level 2 (Orange County Convention Center)
Initial data from the ongoing, investigator-sponsored Phase 1 clinical study of cirmtuzumab in combination with paclitaxel in patients with Her2 negative, metastatic or locally advanced unresectable breast cancer will be presented at the San Antonio Breast Cancer Symposium (SABCS) that will be held December 10-14, 2019, in San Antonio, TX.

Abstract: Phase 1b Trial of Cirmtuzumab and Paclitaxel for Locally Advanced, Unresectable and Metastatic Breast Cancer
Session Name: PS3. Poster Session 3
Session Date: Thursday, December 12, 2019
Session Time: 5:00 PM – 7:00 PM
Location: Hall 1 (Henry B. Gonzalez Convention Center)
About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL and MCL, in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine. CIRM has also provided funding to support development programs for cirmtuzumab and a CAR-T therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.

ROR1 is a potentially attractive target for cancer therapy because it is an oncofetal antigen – a protein that confers a survival and fitness advantage when reactivated and expressed by tumor cells. When expressed by hematologic malignancies such as CLL and MCL, ROR1 acts as a receptor for the tumor growth factor Wnt5a. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to inhibiting Wnt5a activation, specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.

Oncolytics Biotech® Presents Clinical Data at the Fifth Annual Oncolytic Virotherapy Conference Highlighting Definitive Evidence of Systemic Delivery and Replication of Pelareorep in Tumor Tissue

On December 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Matt Coffey, President & CEO of Oncolytics Biotech, will be presenting on a panel as well as delivering a corporate presentation on systemic delivery tomorrow at the Oncolytic Virotherapy Conference (Press release, Oncolytics Biotech, DEC 3, 2019, View Source [SID1234551882]). The panel presentation, "To IT or IV? Intra-Tumoral vs. Intra-Venous Administration," will discuss what indications require IT versus IV, the risks and challenges associated with IT delivery and the views of physicians. Dr. Coffey’s corporate presentation will focus on a recently announced metanalysis of 13 clinical studies and how this intravenous-related data is driving the clinical programs of Oncolytics. The conference takes place December 4 – 5 at the Westin Waterfront Hotel in Boston, MA.

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"Our proven ability to systemically deliver pelareorep through intravenous delivery is a key value driver for Oncolytics," said Dr. Coffey. "I’m excited to see this topic gaining the exposure it deserves and thrilled to be a part of the conversation on this panel at the Oncolytic Virotherapy Conference. I’m also looking forward to presenting data to our peers that outlines pelareorep’s ability to target and infect a majority of tumors, triggering effective immune recruitment following intravenous administration."

Presentations

December 4, 1:40 pm ET

Clinical development of the oncolytic reovirus, pelareorep, for breast cancer

A meta-analysis from 13 different clinical studies on the efficiency of IV delivery
Combination therapy with checkpoint blockade in breast cancer.
Adaptive immune activation following IV delivery and the development of a potential biomarker
December 4, 3:10 pm ET

Panel Presentation: To IT or IV? Intra-Tumoral vs. Intra-Venous Administration

Decide whether OV treatments are most effective when injected directly into the tumour or systemically
Weigh the risks of IT administration with the benefits of a more targeted approach
Consider the views of physicians
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

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.

LABCORP ANNOUNCES EARLY RESULTS OF ITS TENDER OFFER FOR UP TO $300,000,000 PRINCIPAL AMOUNT OF ITS OUTSTANDING 4.625% SENIOR NOTES DUE 2020

On December 3, 2019 LabCorp (NYSE: LH) reported the early results of its previously announced cash tender offer (the Offer) for up to $300,000,000 principal amount (the Tender Cap) of its outstanding $600,000,000 aggregate principal amount of 4.625% Senior Notes due 2020 (the Notes) (Press release, LabCorp, DEC 3, 2019, View Source [SID1234551879]). The terms and conditions of the Offer are described in the Offer to Purchase dated Nov. 18, 2019 (the Offer to Purchase) and remain unchanged.

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The following table sets forth certain information regarding the Offer, including the aggregate principal amount of Notes that were validly tendered and not withdrawn at or prior to 5:00 p.m. EST on Dec. 2, 2019 (the Early Tender Deadline) and the aggregate principal amount of Notes to be accepted for purchase by LabCorp:
174,863,000 $ 174,863,000
LabCorp will accept all Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline, and expects to make payment for the Notes on Dec. 4, 2019 (the Early Settlement Date).

The deadline to validly withdraw tenders has passed. Accordingly, Notes that were already tendered at the Early Tender Deadline may not be withdrawn, except in certain limited circumstances where additional withdrawal rights are required by law.

As previously announced, the total consideration (the Total Consideration) payable for the Notes will be determined at 10:00 a.m. EST today, Dec. 3, 2019, as described in the Offer to Purchase. Holders of Notes validly tendered and not validly withdrawn at or prior to the Early Tender Deadline and accepted for purchase will be eligible to receive the Total Consideration, which will include an early tender premium of $30.00 per $1,000 principal amount of the Notes accepted for purchase (the Early Tender Premium).

LabCorp will continue to accept Notes tendered after the Early Tender Deadline up to the Tender Cap. The Offer will expire at 11:59 p.m. EST on Dec. 16, 2019, unless extended or earlier terminated by LabCorp (the Expiration Date). Holders of Notes who validly tender their Notes following the Early Tender Deadline and on or prior to the Expiration Date will receive the "Tender Offer Consideration" per $1,000 principal amount of any such Notes tendered by such holders that are accepted for purchase, which is equal to the Total Consideration minus the Early Tender Premium. Holders of Notes accepted for purchase by LabCorp will also receive accrued interest from the most recent interest payment date for the Notes up to, but not including, the applicable settlement date. Notes may be subject to proration if the aggregate principal amount of the Notes validly tendered is greater than the Tender Cap.

BofA Securities, US Bancorp, and Wells Fargo Securities are acting as dealer managers for the tender offer. The tender agent and information agent for the tender offer is D.F. King & Co., Inc. Questions regarding the tender offer may be directed to BofA Securities at (980) 387-3907 (collect) or (888) 292-0070 (U.S. toll-free), US Bancorp at (612) 336-7604 (collect) or (877) 558-2607 (U.S. toll-free), and Wells Fargo Securities at (704) 410-4759 (collect) or (866) 309-6316 (U.S. toll-free). Holders who would like additional copies of the offer documents may call the information agent, D.F. King & Co., Inc. at (212) 269-5550 (collect, for banks and brokers) or (888) 625-2588 (toll-free, for all others), or by e-mail at [email protected].

This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell the Notes. The tender offer is being made solely by means of the Offer to Purchase that LabCorp distributed to holders of Notes.