On July 29, 2019 Rainier Therapeutics, Inc., a privately held clinical stage drug development company, reported that updated interim results from the FIERCE-22 trial evaluating vofatamab in combination with pembrolizumab in metastatic bladder cancer will be presented at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress, which will take place September 27 to October 1, 2019 in Barcelona, Spain (Press release, Rainier Therapeutics, JUL 29, 2019, View Source [SID1234537856]).

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"We look forward to presenting updated interim results on clinical activity from our FIERCE-22 trial at ESMO (Free ESMO Whitepaper)," said Scott Myers, Chairman and CEO of Rainier Therapeutics. "This includes longer term follow-up of vofatamab in combination with pembrolizumab in patients with metastatic urothelial carcinoma (bladder cancer), providing a preliminary look at overall survival."

Poster Presentation Details:

Clinical Activity of Vofatamab (V), an FGFR3 Selective Antibody in Combination with Pembrolizumab (P) in Metastatic Urothelial Carcinoma (mUC), Updated Interim Analysis of FIERCE-22

Abstract: 2673

Poster Display Session 3
Presentation Number: 917P
Date: Monday, September 30, 2019
Presentation Time: 12:00 p.m. to 1 p.m.
Location: Poster Area Hall 4

Presenter: Arlene O. Siefker-Radtke, MD, The University of Texas MD Anderson Cancer Center

About FIERCE-22

FIERCE-22 is a Phase 1b/2 trial evaluating vofatamab, a FGFR3-targeted antibody, in combination with pembrolizumab, an immune checkpoint inhibitor, to determine safety, tolerability and preliminary efficacy in the treatment of patients with locally advanced or metastatic bladder cancer who have progressed following platinum-based chemotherapy and who have not received prior immune checkpoint inhibitor therapy.

About Vofatamab

Vofatamab (formerly B-701) is an antibody specifically targeted against the fibroblast growth factor receptor 3 (FGFR3), a known driver of bladder and potentially other FGFR-driven cancers. Vofatamab is the most advanced targeted antibody specific for FGFR3 known by Rainier Therapeutics to be in clinical development. Vofatamab is currently being evaluated in two clinical trials: FIERCE-22 and FIERCE-21.

On July 29, 2019 OncoImmunity AS reported that it has been acquired by NEC Corporation, the renowned Japanese IT and network company, that recently launched its Artificial Intelligence (AI) driven drug discovery business (Press release, NEC OncoImmunity, JUL 29, 2019, View Source [SID1234555210]). OncoImmunity AS will now become a subsidiary of NEC and operate under the name of NEC OncoImmunity AS.

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OncoImmunity AS, founded in 2014, develops software that identifies neoantigen targets for truly personalized cancer vaccines, cell therapies and optimal patient selection for cancer immunotherapy clinical trials. Prior to the acquisition, OncoImmunity AS was funded by a consortium of Norwegian life science and tech investors led by Radforsk, who played a proactive role in developing the company under the guidance of the company’s Chairman Anders Tuv, who was instrumental for and also managed the sales process on behalf of all shareholders. Under the acquisition, NEC will maintain its focus on drug discovery, while NEC OncoImmunity AS continues its neoantigen prediction services.

Both NEC and OncoImmunity AS share a common vision that individualized cancer treatments can be significantly improved by harnessing the power of AI. AI holds tremendous promise in enabling each and every patient to receive the optimal personalized therapy. OncoImmunity AS will benefit from NEC’s proprietary neoantigen prediction modules and its wide array of IT expertise such as data management and security. The OncoImmunity AS platform has unique advantages in accurately predicting antigen presentation to the tumor cell surface, a key determinant for identifying clinically relevant immunogenic neoantigens. By integrating complementary knowledge and resources, this acquisition makes NEC OncoImmunity AS a forerunner in the field of neoantigen prediction. The acquisition signals positive momentum in the field of personalized cancer immunotherapy, where the prediction of immunogenic neoantigens remains a central challenge for clinical success, with two of the predominant players in the neoantigen prediction field now joining forces.

"This acquisition creates a scientific synergy that will enable OncoImmunity AS’s continued dedication to the development of bioinformatics solutions for truly personalized cancer immunotherapy. The combined technology will be of tremendous benefit to our current and future clinical partners," said Dr. Trevor Clancy, Chief Scientific Officer and Co-founder of OncoImmunity AS.

"The OncoImmunity AS team are delighted to be joining the NEC Group and firmly believe that the union will realize great synergies, marrying the mutual strengths of OncoImmunity AS’s and NEC’s neoantigen prediction pipelines with NEC’s expertise in AI, data management and security. These synergies will help strengthen NEC’s individualized immunotherapy programs, whilst simultaneously positioning NEC OncoImmunity AS as the leading neoantigen prediction service provider in the field," said Dr. Richard Stratford, Chief Executive Officer and Co-founder of OncoImmunity AS.

"NEC strongly believes that healthcare based on genomics paves the way for individualized medicine. OncoImmunity AS is a recognized player in the neoantigen prediction field, and their compelling systems are expected to form valuable synergies with NEC. We are confident that this acceleration of development will provide promising new avenues that lead to better cancer treatments," said Osamu Fujikawa, Senior Vice President, NEC Corporation.

On July 29, 2019 Exact Sciences Corp. (NASDAQ: EXAS) and Genomic Health, Inc. (NASDAQ: GHDX) reported that the companies have entered into a definitive agreement under which Exact Sciences will combine with Genomic Health for $72.00 per share in a cash and stock transaction valued at $2.8 billion (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537841]). The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to be completed by the end of 2019.

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Together, Exact Sciences and Genomic Health will create a leading global cancer diagnostics company. The combined company will offer two of the strongest and fastest growing brands in cancer diagnostics, Cologuard and Oncotype DX, providing a robust platform for continued growth. With this enhanced platform, including a commercial presence in more than 90 countries, the combined company expects to continue to increase adoption of current tests, and to bring new innovative cancer diagnostics to patients throughout the world.

On a pro forma basis, the combined company expects to generate revenue of approximately $1.6 billion and gross profit of approximately $1.2 billion in 2020. Additionally, the combination is expected to generate annualized cost synergies of approximately $25 million within the third full year following close, primarily through reducing public company costs and purchasing optimization.

"Uniting the best minds and molecular diagnostics capabilities will advance the fight against cancer. Combining industry pioneers Exact Sciences and Genomic Health is a pivotal step toward building the leading cancer diagnostics company in the world," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is continuing to grow sales and expand adoption of Cologuard at a rapid pace, and Genomic Health’s Oncotype DX is the global standard of care to inform treatment decisions for women with breast cancer. Together, with our collective resources and broader platform, we will be able to provide our existing tests to more people, while also accelerating the development and launch of future cancer diagnostic tests. We are excited to join together two teams who are united in their dedication to making a positive impact on patients’ lives."

"We are very pleased to join forces with Exact Sciences, a company and team with which we have a shared vision to revolutionize the way cancer is diagnosed and treated," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Genomic Health has achieved incredible success over nearly two decades in pioneering cancer diagnostics, and the recent landmark TAILORx trial results set a new standard of care for the use of the Oncotype DX test for women with early-stage invasive breast cancer. This transaction provides immediate value to Genomic Health stockholders through an upfront cash payment, as well as ownership in a combined company with enhanced financial strength and the commercial and R&D capabilities to continue to drive significant growth into the future."

Combining Talented Teams with Proven Capabilities to Create a Leading Cancer Diagnostics Company

Joins two of the strongest brands in cancer diagnostics into one entity and provides platform for continued growth: Cologuard and Oncotype DX, the companies’ leading brands, will respectively continue to help detect colorectal cancer and inform treatment decisions in colorectal, breast and prostate cancer, which collectively represent approximately 40% of all solid tumor incidence.

Exact Sciences’ Cologuard has a total available U.S. screening market of $15 billion, with an additional potential $3 billion opportunity among people ages 45-491. To date, Cologuard has captured less than 6% of the large addressable market of people over 50 years old, and is rapidly building on its 174,000 health care provider customer base, with a goal of reaching 40% share of the market over the long-term. In the second quarter of 2019, Cologuard revenue grew 94% year-over-year.

Genomic Health’s Oncotype IQ portfolio has guided personalized treatment decisions for more than one million cancer patients worldwide, and delivered more than 19% year-over-year overall revenue growth in the second quarter of 2019. Genomic Health estimates that its Oncotype DX suite of products in oncology and urology have a total available market of $2 billion.

Forms best-in-class commercial, R&D and clinical organization, with enhanced scale and scope in cancer diagnostics: The transaction will create a combined R&D team with extensive clinical capabilities and a robust evidence generation engine, complemented by proven regulatory expertise, and key relationships with oncologists. The combined commercial organization will have more than 1,000 team members inclusive of sales, marketing and reimbursement teams. The combined company will have the financial strength to support a high level of investment in R&D. This will support the development of innovative products across the diagnostic paradigm, including the ongoing work to identify proprietary biomarkers across the world’s 15 deadliest cancers, while continuing to advance the adoption of current products.

Provides global infrastructure to accelerate the ability to provide new innovative cancer diagnostics to patients: The combined company will have a commercial presence in more than 90 countries and expanded reach across primary care, oncology, OB/GYN, gastroenterology, and urology to support growth of existing and future cancer tests. The combined company will build upon Genomic Health’s presence in the San Francisco Bay Area, providing lab infrastructure in a state where the Medicare Administrative Contractor participates in the MolDx program, which may facilitate reimbursement of future liquid biopsy products.
Transaction Terms

Under the terms of the agreement, for each share of Genomic Health common stock they own, Genomic Health stockholders will receive $27.50 in cash and $44.50 in shares of Exact Sciences stock, subject to a 10% collar centered on Exact Sciences’ volume-weighted average price for the 45 trading days ended July 26, 2019.

Based on the parties’ closing stock prices as of July 26, 2019, the last trading day prior to today’s announcement, the total per-share consideration represents a premium of approximately 19% to Genomic Health’s volume-weighted average price ("VWAP") for the last 30 trading days. Upon closing, Exact Sciences shareholders are expected to own approximately 91% of the combined company, and Genomic Health stockholders are expected to own approximately 9%.

Transaction Approvals

The transaction is subject to customary closing conditions and regulatory approvals, including the approval of stockholders of Genomic Health. Felix and Julian Baker and certain funds advised by entities with whom they are affiliated, which collectively own approximately 25.3% of the outstanding shares of Genomic Health common stock, have entered into agreements to vote in favor of the transaction.

Advisors

Centerview Partners and XMS Capital Partners are serving as financial advisors to Exact Sciences and Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor. Goldman Sachs & Co. LLC is serving as financial advisor to Genomic Health and Sullivan & Cromwell LLP and Pillsbury Winthrop Shaw Pittman LLP are serving as legal advisors.

Conference Call Information and Transaction Website

Associated presentation materials and an infographic regarding the transaction will be available on the investor relations section of each company’s website at View Source and View Source as well as a joint transaction website at www.leadingcancerdiagnostics.com.

The two companies will host a joint conference call today at 8:00 a.m. ET to discuss this transaction. The call will include a slide presentation and participants are encouraged to view the presentation via webcast at View Source

Date:

Monday, July 29, 2019

Time:

8 a.m. ET, 7 a.m. CT, 5 a.m. PT

Webcast:

The live webcast can be accessed at www.exactsciences.com and
www.genomichealth.com

Domestic callers, dial 877-201-0168

International callers, dial +1 647-788-4901

Access code for both domestic and international callers: 8288326

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay is 8288326. The webcast, conference call and replay are open to all interested parties.

Exact Sciences and Genomic Health Second Quarter 2019 Earnings Results

In separate news releases, Exact Sciences and Genomic Health today both announced their financial results for the second quarter of 2019, ended June 30, 2019. Exact Sciences and Genomic Health will address any questions regarding their earnings on the joint transaction call at 8 a.m. ET. Exact Sciences and Genomic Health have cancelled their previously scheduled earnings calls on July 30, 2019, and August 1, 2019, respectively.

On July 29, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Brian Stuglik, a member of the Board of Directors, has been named Chief Executive Officer (CEO) (Press release, Verastem, JUL 29, 2019, View Source [SID1234537857]).

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"Brian brings deep commercial and biopharmaceutical leadership experience that we believe will accelerate the growth of COPIKTRA and progress overall company goals," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "Throughout his career, Brian has demonstrated an ability to deliver results through a clear strategic vision, focused teams and excellent execution. We are confident that he will capitalize on the significant opportunities in front of the company on behalf of patients, customers and our shareholders."

Mr. Stuglik has more than three decades of experience in US and International pharmaceutical development, product strategy and commercialization, with a focus on Oncology. He spent the majority of his career at Eli Lilly and Company, culminating in his role as Global Vice President and Chief Marketing Officer, Oncology Global Marketing, advancing Lilly Oncology from a single approved product to a portfolio of marketed or late-stage compounds across more than 10 cancer types. In May of this year, he took on a strategic oversight and advisory role to Verastem Oncology’s commercial organization.

"I am honored to join the Verastem Oncology team as CEO and am energized to build on our commitment to patients as we realize the full potential of COPIKTRA and the pipeline," said Mr. Stuglik. "Being a member of the Board of Directors and, more recently, serving as a strategic partner to the team, I have great confidence in Verastem Oncology’s ability to rapidly progress our mission to improve the lives of cancer patients."

Mr. Stuglik will continue to serve as a member of the Board of Directors and will lead the company’s executive team. As recently announced, Dan Paterson, formerly the Chief Operating Officer has assumed the role of President and Chief Operating Officer and Rob Gagnon has expanded his role to Chief Business and Financial Officer.

As previously announced, the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019.

On July 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $199.9 million and screened approximately 415,000 people with Cologuard during the quarter ended June 30, 2019 (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537842]). Second-quarter 2019 revenue and test volume grew 94 percent and 93 percent, respectively, from the same period of 2018.

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"The Exact Sciences team delivered another strong quarter, bringing us closer to our goal of capturing at least 40-percent share of the U.S. colorectal cancer screening market with Cologuard, from about 6 percent today," said Kevin Conroy, chairman and CEO of Exact Sciences. "The foundation we’ve built with our team, infrastructure, and commercial scale positions Exact Sciences well for continued growth."

Second-Quarter 2019 Financial Results

For the three-month period ended June 30, 2019, as compared to the same period of 2018 (where applicable):

Revenue was $199.9 million, an increase of 94 percent, and test volume was 415,000, an increase of 93 percent
Average Cologuard recognized revenue per test was unchanged at $479
Average Cologuard cost per test was $123, an improvement of $2 per test
Gross margin was 74 percent, an increase of 30 basis points
Operating expenses were $182.1 million, an increase of 68 percent
Net loss was $38.4 million, or $0.30 per share, compared to $36.4 million, or $0.30 per share
Non-cash interest expense related to convertible debt was $19.8 million, or $0.16 per share
Cash utilization was $43.3 million, compared to $45.3 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 13,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 174,000 have ordered since the test was launched
2019 Outlook

The company anticipates revenue of $800-$810 million during 2019, an increase from prior guidance of $725-$740 million. The company’s updated guidance does not include the impact of the pending combination with Genomic Health.
The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Forward-Looking Statements" section of this news release.

Second-Quarter and Genomic Health Combination Conference Call & Webcast

In light of the combination with Genomic Health announced separately today, Exact Sciences will not hold its previously announced earnings conference call that had been scheduled for July 30, 2019. The two companies will host a joint conference call today at 8:00 a.m. ET to discuss the transaction as well as each companies’ second-quarter 2019 financial results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8288326. The webcast, conference call, and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.