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

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.

On December 3, 2019 IntelGenx Technologies Corp. (TSX-V:IGX)(OTCQX:IGXT) (the "Company" or "IntelGenx"), a leader in pharmaceutical films, 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 12:30 p.m. Eastern Time (Press release, IntelGenx, DEC 3, 2019, View Source [SID1234551876]).

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The presentation will be broadcast live and archived on the Company’s website at www.intelgenx.com under "Presentations" in the Investors section.

On December 3, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease (Press release, Immunomedics, DEC 3, 2019, View Source [SID1234551873]).

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"We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the Agency during the BLA review," said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC."

On December 3, 2019 FORMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that the company will present at two meetings in December (Press release, Forma Therapeutics, DEC 3, 2019, View Source [SID1234551872]):

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31st Annual Piper Jaffray Healthcare Conference, Thursday, Dec. 5, 2019 at 8:10 a.m. EST in New York, NY.
FORMA Investor Lunch at the 2019 ASH (Free ASH Whitepaper) Annual Meeting, Monday, Dec. 9, 2019 at 12:00 p.m. EST at the Hilton Orlando. Presentations will highlight FT-4202, a novel, selective pyruvate kinase-R (PKR) activator in sickle cell disease, and olutasidenib, an IDH1m inhibitor that acts as a single agent or in combination with azacitidine in acute myeloid leukemia (AML) and myelodysplastic syndrome. This event will be webcast and can be accessed through FORMA Therapeutics Investor page. A replay of the webcast will be available approximately two hours after the completion of the live event.