On December 20, 2018 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported the successful completion of a $400 million Series C financing (Press release, Relay Therapeutics, DEC 20, 2018, View Source [SID1234532195]).

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Relay Therapeutics combines unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry and biology. The integration of these disparate disciplines, tools and cultures enables Relay Therapeutics to overcome challenges that prior attempts have failed to solve and to design therapies against validated but previously intractable targets. Relay Therapeutics’ initial discovery programs in cancer have led to the development of highly selective inhibitors of disease-causing proteins in genomically defined patient populations.

The Series C financing was led by the SoftBank Vision Fund and included participation from additional new investors including Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors GV, Casdin Capital, BVF Partners, EcoR1 Capital, Alexandria Venture Investments, and an affiliate of D.E. Shaw Research also participated in the round.

Proceeds from this financing are anticipated to be used to accelerate the implementation of Relay Therapeutics’ long-term strategy. It will support the expansion of the company’s discovery efforts, advance existing programs into the clinic and bolster its broad platform and diverse team.

"We are at a unique moment in the evolution of drug discovery where we can realize the promise of integrating ever more powerful experimental and computational discovery tools to tackle previously undruggable protein targets. The success of our early programs validates the potential of our platform to create breakthrough therapies that address a broad range of diseases," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics.

"A financing of this magnitude allows Relay Therapeutics to significantly scale and advance both its platform and its pipeline. We are thrilled by the strong support of our investors for our mission, vision and strategy," said Alexis Borisy, Chairman of Relay Therapeutics and Partner at Third Rock Ventures.

"We are proud to support Relay Therapeutics’ world-class team expand its efforts across a larger number of programs and therapeutic areas to develop tomorrow’s life-saving treatments," said Deep Nishar, Senior Managing Partner at SoftBank Investment Advisers, investment adviser to the SoftBank Vision Fund.

On December 20, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported that David Zaccardelli, Pharm. D., has been appointed President and Chief Executive Officer (Press release, Dova Pharmaceuticals, DEC 20, 2018, View Source [SID1234532211]). Dr. Zaccardelli brings substantial specialty pharmaceutical executive leadership and operational expertise, including most notably, serving in several senior management roles at United Therapeutics Corporation. In addition, Jason Hoitt, a seasoned pharmaceutical sales and marketing executive, joins Dova as Chief Commercial Officer. Alex Sapir, the company’s prior President and Chief Executive Officer, is no longer President and Chief Executive Officer of the company, effective as of December 16, 2018.

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"We are very pleased to have both Dr. David Zaccardelli and Jason Hoitt join Dova, as they are highly experienced leaders with the expertise to accelerate the ongoing launch of DOPTELET, prepare for the potential launch in chronic immune thrombocytopenia (ITP), and oversee the clinical development of the chemotherapy-induced thrombocytopenia indication. We believe we have a strong team in place to lead Dova into its next phase of growth" said Paul B. Manning, Chairman of Dova.

"I strongly believe it is a transformational time to join Dova to ensure the full potential of DOPTELET, the first orally administered option for the treatment of thrombocytopenia in patients with chronic liver disease (CLD)," said Dr. David Zaccardelli, newly appointed President and Chief Executive Officer. "In addition, the recently submitted supplemental New Drug Application for patients with ITP provides an opportunity for substantial growth, with the potential for a significant impact on the treatment for patients with ITP. Dova will continue its focus on developing new treatments for patients with unmet medical need."

Dr. Zaccardelli continued, "I am also excited Jason Hoitt is joining Dova to lead the commercial team. He has extensive pharmaceutical experience in both sales and marketing and deep

relationships with hepatologists and gastroenterologists from his roles in the successful launches of Viread HBV while at Gilead Sciences and Incivek, largely regarded as one of the most successful launches in the U.S., while at Vertex."

Separately, the company is providing preliminary estimates of expected net product sales of $2.4 to $2.7 million for DOPTELET for the fourth quarter of 2018. The company also expects any change in year-end inventory held by specialty pharmacies to be flat or potentially decrease compared to the inventory levels on September 30, 2018. The company intends to provide additional detail, including specific metrics, on its fourth quarter and full year 2018 earnings call.

Previously, Dr. Zaccardelli served as the Acting Chief Executive Officer of Cempra Pharmaceuticals, Inc. from December 2016 until the company’s merger with Melinta Therapeutics, Inc. From 2004 until 2016, Dr. Zaccardelli served in several senior management roles at United Therapeutics Corporation, including chief operating officer, chief manufacturing officer and executive vice president, pharmaceutical development and operations. Prior to joining United Therapeutics, Dr. Zaccardelli founded and led a startup company focused on contract pharmaceutical development services, from 1997 through 2003. From 1988 to 1996, Dr. Zaccardelli worked at Burroughs Wellcome & Co. and Glaxo Wellcome, Inc. in a variety of clinical research positions. He also served as director of clinical and scientific affairs for Bausch & Lomb Pharmaceuticals from 1996 to 1997. Dr. Zaccardelli currently serves on the board of directors of Melinta Therapeutics, Inc. (NASDAQ: MLNT), Evecxia Therapeutics and CoreRx, Inc. Dr. Zaccardelli received a Pharm.D. from the University of Michigan.

Prior to Dova, Mr. Hoitt served as Vice President and Head of U.S. sales at Insmed Inc. since 2017. Previously, Mr. Hoitt held roles at Sarepta Therapeutics from 2013 to 2017, including Head of U.S. Sales and Senior Director of Medical Affairs. Prior to Sarepta Therapeutics, Mr. Hoitt, served in various sales and marketing leadership positions at Vertex and Gilead Sciences. Mr. Hoitt has been instrumental in the launches of Arikayce (Insmed), exondys51 (Sarepta Therapeutics), Incivek (Vertex) and Viread HBV (Gilead Sciences).

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-

emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

On December 19, 2018 Auron Therapeutics and Elucidata Corporation reported a scientific collaboration using Elucidata’s AI-based target discovery platform to identify and validate targets for differentiation9-based therapy for Acute Myeloid Leukemia (AML) and eight other oncology indications (Press release, Auron Healthcare, DEC 19, 2018, View Source [SID1234532161]). As part of this collaboration, Elucidata will use its data analytics platform PollyTM, to analyze transcriptomic, metabolomic and epigenetic data from biological samples, as well as disease and treatment response data from patients. This four-year collaboration is among the broadest efforts to date to apply the differentiation-based approach for oncology therapies and has the potential to improve outcomes for patients living with these diseases.

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Elucidata’s AI-based platform combines different forms of omics data using advanced computational analysis techniques to characterize healthy and diseased states at the molecular level. Auron will provide phenotypic data along with transcriptomic, metabolomic and epigenetic data from hundreds of patient samples which will be analyzed on PollyTM to identify and validate targets to develop new therapies with improved treatment efficacy and minimal side effects for a subgroup of patients. The insights generated from this collaboration will further enable stratification of subtypes of different cancers.

"I am extremely impressed by the PollyTM platform that Elucidata has built and the power it has to digest, integrate and analyze large data sets," said Kate Yen, Ph.D., Founder and CEO of Auron Therapeutics. "The unique partnership that we have allows us to work hand-in-hand with the software engineers, scientists, and program managers to rapidly develop novel hypotheses which we can test in the lab. In just a short period of time, we have made significant progress that has had a substantial impact on Auron’s growth."

"With our platform, we are seeking to develop an atlas of differentiation paths of healthy and diseased cells that will help us identify and characterize disease mechanisms," said Abhishek Jha, Co-founder and CEO of Elucidata. "This collaboration with Auron is an incredible opportunity to realize the promise of big data analytics to discover new targets that will deliver more precise medicine to patients."

On December 19, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), reported that based on a subset of data from MD Anderson’s ongoing Phase 2 study, the U.S. Food and Drug Administration (FDA) did not grant Breakthrough Therapy Designation (BTD) to poziotinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 20 mutations (Press release, Spectrum Pharmaceuticals, DEC 19, 2018, View Source;19.htm [SID1234532181]). The company’s overall development plan and timeline for a New Drug Application (NDA) filing based on the first cohort of the ZENITH20 trial remains unchanged.

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Breakthrough Therapy Designation is one of several FDA programs designed to expedite the review of drugs to treat serious or life threatening conditions. Spectrum’s BTD application included data from 30 patients from the MD Anderson Phase 2 study who had failed platinum-based chemotherapy. The data demonstrated a confirmed objective response rate of 40% and median duration of response of 6.6 months. The safety profile in this subset was consistent with historical data published on poziotinib and other tyrosine kinase inhibitors. The historical objective response rates for mutation specific NSCLC patients range between 0% and 8% with tyrosine kinase inhibitors and for non-mutation specific NSCLC patients range between 0.8% and 22.9% with other treatments.

"Our enthusiasm for poziotinib, our commitment to the program, and our overall development plan remain unchanged," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We will continue to work with the FDA to achieve the fastest route to approval of poziotinib based on our ZENITH20 study."

ZENITH20 is a Spectrum-sponsored, open-label, single-arm, multi-center, global Phase 2 study evaluating more than 300 NSCLC patients with EGFR or HER2 exon 20 insertion mutations. The study consists of four cohorts, each of which is independently powered for a pre-specified statistical hypothesis.

"Poziotinib’s overall development program is robust, and the clinical profile remains very attractive in an area of high unmet need," said Francois Lebel, M.D., F.R.C.P.C, Chief Medical Officer of Spectrum Pharmaceuticals. "Data required for the NDA filing for previously treated NSCLC patients with EGFR exon 20 insertion mutations is expected to come from an 87-patient cohort in our ZENITH20 study. We expect to complete enrollment in this cohort in the first quarter of 2019, and announce topline data in the second half of 2019."

11500 S. Eastern Ave., Ste. 240 • Henderson, Nevada 89052 • Tel: 702-835-6300 • Fax: 702-260-7405 • www.sppirx.com • NASDAQ: SPPI

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Conference Call Details:
Wednesday, December 19, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 1577888
International: (973) 796-5077, Conference ID# 1577888
The conference call will also be webcast live. To access the webcast, please visit the Investor Relations page of the Spectrum Pharmaceuticals website at View Source
For interested individuals unable to join the call, a replay will be available from December 19, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through December 26, 2018, until 7:30 p.m. ET/4:30 p.m. PT.
Domestic Replay Dial-In: (855) 859-2056, Conference ID# 1577888
International Replay Dial-In: (404) 537-3406, Conference ID# 1577888

About Poziotinib
Poziotinib is a novel, oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. Spectrum received exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by Spectrum and Hanmi in several mid-stage trials in multiple solid tumors.

About ZENITH20

The ZENITH20 study is Spectrum-sponsored, Phase 2, open-label, single-arm, multi-center, global study for patients with EGFR or HER2 exon 20 insertion mutations in NSCLC. It consists of four cohorts, each of which is an independent study with pre-specified statistical hypotheses and statistical power. There are two cohorts in the previously-treated setting and two in the first-line setting. The full poziotinib targeted therapy clinical program is focused on four development areas for EGFR and HER2 mutations, including previously treated NSCLC, first-line NSCLC, treatment of other solid tumors and combination therapy.

On December 19, 2018 On December 19, 2018, BeiGene, Ltd. (the "Company") reported that it received notice from Merck KGaA ("Merck KGaA") that Merck KGaA was terminating for convenience the parties’ License Agreement dated December 10, 2013, as amended, for the Company’s investigational RAF dimer inhibitor lifirafenib (BGB-283) in the People’s Republic of China ("PRC") (Filing, 8-K, BeiGene, DEC 19, 2018, View Source [SID1234532301]). As a result of such termination, Merck KGaA’s exclusive right of first negotiation to acquire exclusive commercialization rights under the lifirafenib RAF dimer program in the PRC was terminated and the Company is no longer required to pay Merck KGaA royalties on sales of lifirafenib in the PRC or entitled to receive future milestone payments from Merck KGaA for lifirafenib. The Company’s ex-PRC agreement with Merck KGaA on lifirafenib was terminated in March 2017.

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