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.

Veracyte Acquires Exclusive License to NanoString Diagnostics Platform, Positioning Veracyte To Expand Its Genomic Testing Business Globally

On December 3, 2019 Veracyte (Nasdaq: VCYT) reported that it has executed a definitive agreement with NanoString for the exclusive global license to the nCounter platform for diagnostic use (Press release, Veracyte, DEC 3, 2019, View Source [SID1234551878]). The strategic transaction positions Veracyte to expand its genomic diagnostics business globally, with the ability to deliver its advanced genomic tests to physicians and their patients via hospital and clinical laboratories throughout the European Union and other parts of the world.

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Veracyte believes that the transaction will ultimately enable it to access a global market worth more than $40 billion for its current and pipeline products, while expanding its margins through test menu expansion on the nCounter platform. The elegantly designed, FDA-cleared, automated nCounter system is expected to enable broad testing utility through its ability to simultaneously analyze RNA, DNA or protein targets in up to 800 genes.

Veracyte expects to begin offering its Envisia classifier, for use in idiopathic pulmonary fibrosis diagnosis, to international customers in 2021 as a kit-based test that runs on the nCounter system. The company expects its in-development nasal swab classifier, for use in lung cancer diagnosis, to follow on the nCounter system in 2022, after the test becomes available in Veracyte’s CLIA laboratory in the United States in early 2021. The nCounter system can also run additional genomic tests developed by Veracyte, as well as by potential diagnostics or biopharmaceutical partners seeking access to global markets.

As part of the transaction, Veracyte has also acquired the NanoString Prosigna breast cancer prognostic test and in-development LymphMark lymphoma subtyping assay, further expanding the company’s oncology portfolio.

"NanoString has developed a versatile, world-class diagnostics platform, which we believe will enable us to realize our vision of becoming a leading global provider of advanced genomic testing," said Bonnie H. Anderson, Veracyte’s chairman and chief executive officer. "We are especially excited about the opportunity to bring our noninvasive nasal swab classifier to a global market, where it can help save more lives in the fight against lung cancer. Ultimately, this transaction will further our ability to inform clinical care decisions throughout the patient journey in cancer and other clinical indications, while allowing us to deliver profitable, long-term growth for our shareholders."

"Veracyte is a world-class diagnostics company with an expanding menu of innovative genomic tests that are well-positioned for successful global commercialization," said Brad Gray, president and chief executive officer of NanoString. "They are the ideal company to help ensure that our nCounter-based diagnostic platform can benefit as many patients around the world as possible."

Veracyte has agreed to pay NanoString$40 million in cash and $10 million in Veracyte common stock, and up to an additional $10 million in cash contingent upon the commercial launch of Veracyte diagnostic tests for use on the platform.

Veracyte expects to realize a modest revenue contribution through the transaction of $6 million to $8 million in 2020, with a neutral impact to cash flow from the current business.

Transaction Details and Rationale

World-Class Technology and Instrumentation Platform – Exclusive worldwide clinical diagnostic rights to the nCounter system technology and instrumentation platform provides Veracyte with pricing, margin and other commercial flexibility for global expansion that would not be possible through third-party distribution partners. The system’s automated and simple-to-use design requires less than two hours of hands-on time, making genomic testing more accessible to patients through laboratories that previously may not have had the resources or expertise to perform such complex testing.

Veracyte expects the expertise of the key technical team that will join the company as part of the transaction to facilitate test integration. Veracyte’s product discovery and certain commercial products will continue to be powered by its RNA whole-transcriptome sequencing platform, enabling continued expansion of its world-class biorepositories of patient samples in key clinical indications.
Global Commercial Infrastructure – Key members of the NanoString global diagnostics sales, marketing, medical affairs and distribution teams will join Veracyte, enabling Veracyte to accelerate its global expansion initiatives.
Expanded Genomic Test Menu – The Prosigna test is available on the nCounter system globally and in the United States to inform risk of recurrence in subgroups of women with breast cancer. Veracyte intends to offer the Prosigna test as a distributed kit within and outside of the United States. It will also add the test to its menu of advanced genomic products offered in the United States through its CLIA-certified laboratory. The LymphMark lymphoma subtyping test is currently in development.
Advisors

Fenwick & West LLP is serving as legal advisor to Veracyte.

Conference Call and Webcast

Veracyte will host a conference call and webcast to discuss the transaction today at 5:30 p.m. Eastern Time. The call will include a slide presentation, which participants may view at View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at the above link.

The conference call can be accessed as follows:

US/Canada Participant Dial-In Number (toll-free):

(855) 541-0980

International Dial-In Number:

(970) 315-0440

Conference I.D.:

5672629

Sermonix to Co-sponsor ‘Candid Conversations’ Patient Advocacy Panel With Breastcancer.org at San Antonio Breast Cancer Symposium

On December 3, 2019 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company focused on the development of female-specific oncology products in the precision medicine metastatic breast cancer arena, reported it will co-sponsor a breast cancer patient advocacy panel with Breastcancer.org at the 2019 San Antonio Breast Cancer Symposium (SABCS). The symposium will take place December 10-14 (Press release, Sermonix Pharmaceuticals, DEC 3, 2019, View Source [SID1234551877]).

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Candid Conversations on Mets, Sex, and Side Effects: a Panel Discussion With Leading Breast Cancer Oncologists, Women’s Health Experts and Patients will be held at 7:30 p.m. CST on Dec. 11, 2019 at the Grand Hyatt San Antonio. Discussion will focus on metastatic breast cancer quality of life issues including sexual intimacy, bone health and joint pain. Panelists will also discuss liquid biomarkers for disease progression in the metastatic setting.

"Sermonix is pleased to join Breastcancer.org in co-sponsoring this innovative event at the San Antonio Breast Cancer Symposium," said Dr. David Portman, founder and CEO of Sermonix Pharmaceuticals. "It is essential we in the breast cancer research and development community hear the voice of the patient and keep their most important quality-of-life issues top of mind in confronting this challenging disease."

Joining Dr. Portman on the patient advocacy panel will be:

Kelli Davis, metastatic breast cancer patient and director of social media at Metavivor
Dr. Stephanie Graff, director of the Breast Cancer Program at Sarah Cannon Cancer Institute at HCA Midwest Health and associate director of the Breast Cancer Research Program at Sarah Cannon Research Institute
Dr. Kelly Shanahan, Ob/Gyn, Metavivor board member, metastatic breast cancer patient and advocate
Dr. Marisa Weiss, founder and chief medical officer at Breastcancer.org
Dr. Graff, an award-winning writer and social media influencer, has broad experience as a principal investigator on numerous clinical trials. She received the Frist Humanitarian Award for her work improving the lives of people in her healthcare community, and serves on the boards of the American Cancer Society Kansas/Kansas City Area and The Research Foundation.

"This symposium is a great opportunity for breast cancer patients and advocates to come together with experts in both women’s health and breast oncology, evolving the discussion on ways to optimize quality of life in ER+ metastatic breast cancer," said Dr. Graff.

Davis, an outspoken advocate on behalf of women living with the disease, was diagnosed with stage I breast cancer in 2009 and stage IIIc in 2013. She learned she had stage IV, or metastatic, breast cancer in late 2014.

"As women begin to live longer with metastatic breast cancer, quality of life must become an increasingly essential consideration," said Davis. "True collaboration between patients, physicians, researchers and drugmakers is how quality of life improvements will become possible. It’s the intersection of real and lasting hope."

Sermonix will also hold a Scientific Steering Expert Advisory Board meeting and host an exhibit booth during SABCS. The booth, No. T9, will be accessible Dec. 11-13 from 10:45 a.m.-5 p.m. CST at the Henry B. Gonzalez Convention Center in San Antonio.