On March 3, 2020 Voluntis (Euronext Paris, Ticker: VTX – ISIN: FR0004183960), a leader in digital therapeutics, and Bristol-Myers Squibb Company (NYSE:BMY) reported a collaboration agreement to create and investigate digital therapeutic solutions that will support cancer patients (Press release, Bristol-Myers Squibb, MAR 3, 2020, View Source [SID1234555111]). Leveraging Theraxium Oncology, Voluntis’ core platform for digital therapeutics in oncology, the collaboration will evaluate potential solutions that will support management of patient symptoms and remote monitoring by healthcare providers.

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The goal is that the digital therapeutic, once researched and developed, would provide patients access to a mobile app that would support treatment and track symptoms. The app will be developed to embed evidence-based algorithms intended to provide patients with real-time recommendations for self-management of symptoms related to their therapy. The parties will also investigate how the solution could enable patients to more effectively communicate with their health care providers, capture and track symptoms, and receive a personalized supportive care plan.

On March 3, 2020 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, and QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA), a leading global provider of molecular diagnostics and sample preparation technologies, reported that their boards of directors, as well as the managing board of QIAGEN N.V., have unanimously approved Thermo Fisher’s proposal to acquire QIAGEN for €39 per share in cash (Press release, Qiagen, MAR 3, 2020, View Source [SID1234555127]). The offer price represents a premium of approximately 23% to the closing price of QIAGEN’s common stock on the Frankfurt Prime Standard on March 2, 2020, the last trading day prior to the announcement of the transaction. Thermo Fisher will commence a tender offer to acquire all of the ordinary shares of QIAGEN.

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The transaction values QIAGEN at approximately $11.5 billion at current exchange rates, which includes the assumption of approximately $1.4 billion of net debt.

"We are excited to bring together our complementary offerings to advance our customers’ important work, from discovery to diagnostics," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "This acquisition provides us with the opportunity to leverage our industry-leading capabilities and R&D expertise to accelerate innovation and address emerging healthcare needs. For shareholders, we expect the transaction to be immediately accretive and to generate significant cost and revenue synergies."

QIAGEN is a leading provider of life science and molecular diagnostic solutions and employs approximately 5,100 people at 35 locations in more than 25 countries. The company generated 2019 revenue of $1.53 billion. Its sample preparation technologies are used to extract, isolate and purify DNA, RNA and proteins from a wide range of biological samples. The company’s assay technologies are then used to amplify and

enrich these biomolecules to make them readily accessible for analysis. In addition, QIAGEN’s instruments can be used to automate these workflows, while its bioinformatics systems provide customers with relevant, actionable insights.

"Our vision at QIAGEN has always been to make improvements in life possible with our differentiated Sample to Insight molecular testing solutions," said Thierry Bernard, interim chief executive officer of QIAGEN N.V. and senior vice president, head of the molecular diagnostics business area. "This strategic step with Thermo Fisher will enable us to enter a promising new era and will give our employees the opportunity to have an even greater impact. The combination is designed to deliver significant cash value to our shareholders, while enabling us to accelerate the expansion of our solutions to provide customers worldwide with breakthroughs that advance our knowledge about the science of life and improve health outcomes."

Casper concluded, "We look forward to welcoming QIAGEN’s employees to Thermo Fisher and are excited about the new opportunities we’ll have to advance precision medicine through new molecular diagnostics and improved life sciences workflows."

Benefits of the Transaction

Expands Specialty Diagnostics Portfolio with Attractive Molecular Diagnostics Capabilities, Including Infectious Disease Testing. Thermo Fisher has built leading specialty diagnostics capabilities, including allergy and autoimmunity, transplant diagnostics and clinical oncology testing. QIAGEN has a strong presence in molecular diagnostics with a product portfolio focused on infectious disease and other growth opportunities. The combined company will accelerate the development of higher-specificity, faster and more comprehensive tests that may improve patient outcomes and reduce the cost of care.

Complementary Offering Enhances Unique Value Proposition for Life Sciences Customers. For life sciences researchers, QIAGEN’s innovative sample preparation, assay and bioinformatics technologies are complementary to Thermo Fisher’s genetic analysis and biosciences capabilities. As an example, with an expanded portfolio, Thermo Fisher will be able to provide research customers with broader capabilities to accelerate discovery and enable scientific breakthroughs.

Commercial and Geographic Reach Expand Customer Access. Thermo Fisher will be able to leverage its extensive commercial reach, including its Fisher Scientific customer channels and comprehensive e-commerce platforms, to expand customer access to QIAGEN’s product portfolio. Furthermore, given Thermo Fisher’s leading presence in high-growth and emerging markets, QIAGEN will be able to further penetrate these regions.

Delivers Attractive Financial Benefits through the PPI Business System, Including Proven Integration Approach. The transaction is expected to be immediately accretive to Thermo Fisher’s adjusted EPS after close. Thermo Fisher expects to realize total synergies of $200 million by year three following the close, consisting of $150 million of cost synergies and $50 million of adjusted operating income1 benefit from revenue synergies.

Financing and Approvals

The transaction, which is expected to be completed in the first half of 2021, is subject to the satisfaction of customary closing conditions, including the receipt of applicable regulatory approvals, the adoption of certain resolutions relating to the transaction at an Extraordinary General Meeting of QIAGEN’s shareholders, and completion of the tender offer.

Adjusted earnings per share and adjusted operating income are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

Thermo Fisher has obtained committed bridge financing. Permanent funding is expected to come from cash on hand and the issuance of new debt. The transaction is not subject to any financing condition.

Advisors

J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are serving as financial advisors to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz is serving as legal counsel. For QIAGEN, Goldman Sachs International is serving as lead financial advisor and Barclays Bank PLC is serving as financial advisor, while De Brauw Blackstone Westbroek NV, Linklaters LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C. are serving as legal counsel.

Conference Call and Webcast

Thermo Fisher will host a conference call and webcast at 8:30 a.m. Eastern Time today to provide more information on this announcement. The webcast and accompanying slides can be accessed in the Investors section of www.thermofisher.com. An audio archive of the call will be available in that section of the website until March 17, 2020.

On March 3, 2020 Senti Biosciences, Inc., the gene circuit company focused on outsmarting complex diseases with intelligent medicines, reported that Jose Iglesias, M.D., has joined the company as Chief Medical Officer (CMO) (Press release, Senti Biosciences, MAR 3, 2020, View Source [SID1234555145]). In this position, Dr. Iglesias will lead the clinical development of Senti’s next-generation cell and gene therapy product candidates focused on the treatment of solid and liquid tumors.

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"We are excited to have Jose join our team as chief medical officer," said Tim Lu, CEO of Senti Biosciences. "He brings a wealth of experience in oncology clinical development to Senti in that he has designed and implemented clinical trials of novel cancer therapies across all development phases. This expertise will be critical as we advance our SENTI-101 program into the clinic later this year, in addition to our upcoming pipeline programs."

"I’m thrilled to be joining such a talented and diverse team at Senti Biosciences, a company that is pioneering the development of gene circuit-based therapies," said Dr. Iglesias. "I look forward to stewarding these novel therapies through the clinic and into approved treatments for cancer patients with high unmet needs."

Dr. Iglesias has more than three decades of global clinical development experience in the biopharmaceutical industry. He has previously held multiple CMO and clinical development leadership roles at companies such as Abraxis, Celgene, Eli Lilly, Boston Biomedical, Apobiologix, Biothera Pharmaceuticals and Bionomics. In these roles, he has led the clinical development of biologics and small molecules in both solid and liquid tumors, bringing extensive experience to Senti’s growing oncology pipeline. While at Abraxis and Celgene, Dr. Iglesias designed and implemented the Phase 3 development of ABRAXANE for the treatment of metastatic pancreatic, breast and non-small cell lung cancers.

About Senti Biosciences’ SENTI-101 Program

Senti’s gene circuit platform enables the programming of any cell and gene therapy modality, including immune cells, stem cells and viral vectors. Senti’s SENTI-101 program uses tumor-homing allogeneic cells as a drug delivery vehicle to achieve localized, combinatorial expression of two cytokines, IL-12 and IL-21. This pair of cytokines activates a multifactorial immune response against solid tumors, and turns immunologically cold tumors hot. In the second half of 2020, Senti intends to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human clinical study of SENTI-101 in patients with ovarian cancer.

On March 3, 2020 Cernostics, a leader in the development of AI-driven image analysis technologies for precision medicine testing, reported the publication of positive data from a blinded, independent validation study of its breakthrough TissueCypher Barrett’s Esophagus Assay by the American Journal of Gastroenterology (Press release, Cernostics, MAR 3, 2020, View Source [SID1234555112]).

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As the first and only precision medicine test for esophageal pinch biopsies, TissueCypher is designed, developed, and independently validated to identify patients with Barrett’s esophagus (BE) who are at higher risk of developing esophageal adenocarcinoma (EAC) and may require earlier therapeutic intervention or more frequent endoscopic surveillance. The test has now been validated in six independent clinical studies with leading clinical centers around the world including Cleveland Clinic, University of Pennsylvania Medical Center, Geisinger Health, and Academic Medical Center in Amsterdam.

"TissueCypher addresses one of the most pressing unmet needs in our field – the identification of which Barrett’s patients will progress to cancer. A diagnostic test that helps address this problem will be of great use clinically," says Nicholas J. Shaheen, M.D., MPH, Chief, Division of Gastroenterology and Hepatology, UNC HealthCare, Chapel Hill, NC; Bozymski-Heizer Distinguished Professor of Medicine, University of North Carolina School of Medicine, and current member of the Cernostics’ Medical Advisory Board.

"With its combination of morphology and molecular insights to assess progression risk, TissueCypher addresses a number of challenging issues for GI pathologists. Of most concern is differentiating non-dysplastic BE (NDBE) patients that are histologically identical but progress at significantly different rates to high-grade dysplasia (HGD) or EAC," says Jon M. Davison, MD, pathologist and co-author of the article and Associate Professor, Department of Pathology, University of Pittsburgh School of Medicine. Davison continues, "This test also adds further prognostic clarity to cases diagnosed as indefinite for dysplasia (IND)."

The peer-reviewed article, written by researchers from the University of Pittsburgh School of Medicine, Cleveland Clinic, and Cernostics, Inc., presents a blinded, independent validation of the TissueCypher Assay for predicting future development of EAC in patients with BE.

In the study that was funded by the NIH/NCI, patients with BE who progressed to HGD or EAC after at least one year following endoscopy (n=58) were matched to patients with BE without disease progression after a median of seven years’ surveillance (n=210). Baseline biopsies with expert GI pathologist diagnoses of NDBE, IND or LGD were blindly tested and classified by the TissueCypher Assay into high-risk and low-risk for future progression. Results demonstrated that patients classified as high-risk by TissueCypher were at 4.7-fold increased risk for HGD/EAC compared to those classified as low-risk group (p<0.0001). In addition, patients with no sign whatsoever of dysplasia, based on expert pathologist review, who scored high-risk by TissueCypher progressed at a higher rate (26%) than patients with expert pathologist confirmed LGD (21.8%). This is a crucial finding as these are the "at-risk" group who are missed by the current standard of care. A high-risk score with TissueCypher in patients with non-dysplastic BE may support early use of endoscopic eradication therapy or increased surveillance to prevent development of HGD/EAC.

"This independent validation of TissueCypher adds to the robust body of clinical evidence supporting this test as an important tool for managing patients with BE," said Mike Hoerres, CEO, Cernostics.

"TissueCypher is unique and powerful in that it objectively extracts highly meaningful cellular, molecular and morphologic features from standard pinch biopsies. It fits seamlessly into current clinical care, and no special brushes or alternative esophageal biopsy collection devices are required. So, physicians get an individualized risk score from the biopsies removed during an upper GI endoscopy, which supports clinical decision-making," said Hoerres.

"The Cernostics product, TissueCypher, fits seamlessly into a physician’s current clinical practice. No extra steps are needed in the endoscopy suite, as some systems today require," said Anthony Infantolino, M.D., AGAF, FACG, FACP, gastroenterologist, Professor of Medicine at the Sidney Kimmel Jefferson Medical College and Associate Chairman of the Division of Gi/Hepatology and Director of The Jefferson Barrett’s Center and long-time user of TissueCypher. "The test evaluates pinch biopsies taken during endoscopy and gives me the adjunctive information I need to determine my patient treatment plan."

TissueCypher is commercially available as a laboratory developed test (LDT) through Cernostics’ clinical reference lab located in Pittsburgh, Pennsylvania.

About Barrett’s Esophagus

BE affects more than three million Americans, occurring when chronic exposure to stomach acid causes the esophageal cell lining to deteriorate and undergo changes that can create an environment for cancer. Without treatment, Barrett’s can lead to EC, with a poor 5-year survival of less than 20%. Today, Barrett’s is commonly managed by surveillance, involving regular endoscopic procedures with biopsy, monitoring disease progression, and GERD-related drug therapy to control symptoms and prevent esophageal injury.

About TissueCypher Barrett’s Esophagus Assay

TissueCypher is a laboratory developed test (LDT) provided as a testing service by Cernostics clinical reference laboratory in Pittsburgh, PA. The test is indicated for evaluation of esophageal pinch biopsies (or Endoscopic Mucosal Resection [EMR] specimens) from patients confirmed to have Barrett’s esophagus with histology of no dysplasia (ND), indefinite for dysplasia (IND) or low- grade dysplasia (LGD). The TissueCypher platform utilizes a multiplexed fluorescence imaging platform that rapidly extracts high dimensional, quantitative data on multiple epithelial, stromal and morphometric biomarkers in biopsies and assess multiple pathways associate with malignant progression.

Experience TissueCypher for yourself by visiting www.ExperienceTissueCypher.com and choosing one of several charts to find a patient comparable to one in your own Barrett’s pool and see how TissueCypher provides adjunctive information to support your clinical decisions.

On March 3, 2020 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, reported its financial and operational results for the year ended December 31, 2019 (Press release, Sierra Oncology, MAR 3, 2020, View Source [SID1234555128]).

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"Our focus is on achieving regulatory and commercial success with our Phase 3 drug candidate, momelotinib, which may become the first approved therapeutic capable of treating all three hallmarks of myelofibrosis; anemia, constitutional symptoms and enlarged spleen. Given its potentially unique profile, momelotinib could command an important role in the poorly addressed anemic and thrombocytopenic first-line and second-line myelofibrosis patient populations," said Dr. Nick Glover, President and CEO of Sierra Oncology. "During the fourth quarter of 2019, we launched the MOMENTUM Phase 3 clinical trial, setting Sierra on course to deliver top-line data in late 2021 and positioning momelotinib for potential registration filing in 2022. Our focus now is on activating global clinical trial sites over the coming months and driving enrollment for MOMENTUM, and we look forward to providing ongoing updates on our progress throughout this year."

"Myelofibrosis is characterized by progressive anemia and thrombocytopenia, and current JAK inhibitor therapies can induce or further exacerbate this myelosuppression, limiting their use in first line treatment and resulting in a population of second line patients who are no longer able to benefit from such therapies. Conversely, we believe momelotinib’s ability to address anemia, while either sparing platelets or reversing thrombocytopenia, are important potential drivers of its commercial opportunity. We plan to further highlight momelotinib’s differentiated durability, safety and efficacy profile during 2020 with additional dissemination of emerging data from the two previously completed SIMPLIFY Phase 3 trials that compared momelotinib head-to-head with ruxolitinib," added Dr. Glover. "Given momelotinib’s distinct clinical profile, we believe our drug candidate is also well positioned amongst the JAK inhibitor class for emerging combination approaches targeting myelofibrosis."

2019 Highlights for Momelotinib:

During the second quarter, Sierra obtained regulatory clarity with the FDA and announced the design of the MOMENTUM Phase 3 clinical trial intended to support the potential registration of momelotinib. Sierra also announced that Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, had been named Chief Investigator of the MOMENTUM trial.
Sierra also reported during the second quarter that the FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.
During the fourth quarter, Sierra launched the MOMENTUM clinical trial for patients with myelofibrosis. The randomized double-blind global Phase 3 trial is designed to confirm the efficacy of momelotinib on myelofibrosis symptoms, transfusion independence and splenomegaly, as compared to danazol. The trial is targeting enrollment of 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05). Data from MOMENTUM, along with data from more than 820 myelofibrosis patients previously treated with momelotinib in prior clinical studies, will form the basis of the global registration strategy for momelotinib.
During the fourth quarter, new analyses of RBC transfusion data from SIMPLIFY-1, a double-blind Phase 3 trial of momelotinib head-to-head versus ruxolitinib in JAK inhibitor naïve patients, were presented in a poster by Dr. Ruben Mesa, Director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida. These analyses demonstrated that patients who received momelotinib had significantly decreased transfusion requirements compared to those treated with ruxolitinib, including an odds ratio of nearly 10 for receiving no transfusions during the 24-week study period. Transfusion dependency and moderate to severe anemia are critical negative prognostic factors for overall survival in myelofibrosis.
Year End 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $53.2 million for the year ended December 31, 2019, compared to $41.1 million for the year ended December 31, 2018. In addition to a non-cash charge of $10.5 million pertaining to the obligation to issue common stock and a warrant in consideration for meaningfully reduced royalty rates and elimination of a near term milestone payment in an amendment to our Asset Purchase Agreement with Gilead Sciences, Inc. (Gilead), the increase was primarily due to costs related to momelotinib, including a $12.2 million increase in clinical trial and development costs, a $2.5 million increase in third-party manufacturing costs and a $1.4 million increase in personnel-related and allocated overhead costs. These increases were partially offset by a $3.0 million upfront fee paid to Gilead to acquire momelotinib in 2018 and decreases in SRA737 and SRA141 costs, including a $5.0 million decrease in clinical trial costs primarily related to SRA737, a $4.3 million decrease in third-party manufacturing costs, and a $2.1 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $3.9 million and $4.5 million for the year ended December 31, 2019 and 2018, respectively.

General and administrative expenses were $13.7 million for the year ended December 31, 2019, compared to $14.3 million for the year ended December 31, 2018. This decrease was primarily due to decreases in personnel-related and allocated overhead costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $2.3 million for the year ended December 31, 2019 and 2018, respectively.

Other income (expense), net was $21.4 million of other expense, net for the year ended December 31, 2019, compared to $1.8 million of other income, net for the year ended December 31, 2018. The increase was primarily attributable to a non-cash charge of $20.9 million related to the change in fair value of warrant liabilities and offering expenses of $1.3 million pertaining the issuance of the warrants in the 2019 public offering and a $0.7 million increase in interest expense incurred on the term loan that was repaid in December 2019.

For the year ended December 31, 2019, Sierra incurred a GAAP net loss of $88.3 million compared to a GAAP net loss of $53.3 million for the year ended December 31, 2018. The GAAP net loss for the year ended December 31, 2019 includes a non-cash charge of $20.9 million, related to the change in fair value of warrant liabilities included in other income (expense), net and a non-cash charge of $10.5 million pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above. In January 2020, Sierra fulfilled this obligation, issuing 725,283 shares of common stock to Gilead and a warrant to purchase an equivalent amount of common stock.

Non-GAAP adjusted net loss was $51.2 million for the year ended December 31, 2019, compared to a non-GAAP adjusted net loss of $46.5 million for the year ended December 31, 2018. Non-GAAP adjusted net loss excludes expenses related to the change in fair value of warrant liabilities, the securities issuance obligation, and stock-based compensation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP and non-GAAP financial measure.

Cash and cash equivalents totaled $147.5 million as of December 31, 2019, compared to $106.0 million as of December 31, 2018. This increase was due to an underwritten public offering in November 2019, pursuant to which the company raised gross proceeds of $103.0 million (net proceeds of $97.7 million). This increase was offset by cash used in operating activities of $51.2 million and the full repayment of a term loan in December 2019 in the amount of $5.4 million, including prepayment and final payment fees associated with terminating the debt facility.

In January 2020, all of the Series A convertible voting preferred stock converted into shares of common stock. As of January 31, 2020, there were 10,395,732 total shares of common stock outstanding and warrants to purchase 11,102,251 shares of common stock, with an exercise price equal to $13.20 per share. At December 31, 2019 were 327,862 shares issuable upon exercise of stock options and a warrant.

The company anticipates its current resources will be sufficient to execute on its development strategy for momelotinib into the second half of 2022. In addition, the Series B warrants issued in the underwritten public offering in November 2019, may only be exercised by paying the exercise price in cash, and will expire on the 75th day anniversary following the announcement of top-line data from the MOMENTUM Phase 3 trial. If these Series B warrants are fully exercised, the company will receive approximately $34.0 million in proceeds.

Conference Call Information

Today at 8:00 am Eastern Time, Sierra’s management will host a conference call to discuss the company’s and operational results for 2019 and provide a business update for 2020.

Date and Time: Tuesday, March 3 at 8:00 am ET

Domestic (Toll Free- US): 1-888-394-8218
International (Toll): 1-323-701-0225
Conference ID: 1052679
Webcast Link: www.sierraoncology.com
Direct Link: View Source

Call registration is available through the Sierra Oncology website at www.sierraoncology.com. An archive of the presentation will be accessible after the event through the Sierra Oncology website.