On August 5, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported it has acquired an exclusive global license from AstraZeneca (LSE/STO/NASDAQ: AZN) for AZD5153, a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode (Press release, Sierra Oncology, AUG 5, 2021, View Source [SID1234585951]). Sierra plans to initiate a Phase 2 study examining momelotinib in combination with AZD5153 in myelofibrosis patients in the first half of 2022.

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"This global in-licensing deal is of two-fold importance to Sierra’s long-term strategy. First, it brings another novel compound into the Sierra development pipeline, expanding our opportunity to deliver transformative therapies for patients with rare cancers. Second, it may allow us to enhance and extend our ability to treat myelofibrosis patients, building on momelotinib’s potential as a cornerstone therapy," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology.

Inhibitors of the Bromodomain and Extra-terminal Domain (BET protein family consisting of BRD2, BRD3, BRD4 and BRDT) can modify a range of pathological cellular processes, including the initiation and continuation of transcription and cell cycle control. BET inhibition can lead to decreased inflammatory cytokine release, anti-fibrotic activity and reduced mutant cell proliferation, all of which are indicative of disease-modifying effects. Several BET inhibitors are under clinical investigation in multiple solid tumor and hematologic indications, including myelofibrosis.

AZD5153 is a selective BRD4 inhibitor with a novel bivalent binding mode that inhibits both protein bromodomains, resulting in improved potency. Unlike currently available JAK inhibitors, momelotinib is not myelosuppressive, therefore the combination of momelotinib and AZD5153 may provide an efficacy and safety advantage over other JAK inhibitor plus BET inhibitor combinations and allow for prolonged dose intensity and treatment duration. This trial will be designed to provide preliminary proof of concept for a future confirmatory study and support potential additional studies of momelotinib with other novel agents in development for myelofibrosis. Trial initiation is anticipated to begin in the first half of 2022.

Mark Kowalski, MD, PhD, Chief, Research and Early Development at Sierra added, "The combination of JAK inhibition and BET inhibition has been identified as a promising emergent approach for the treatment of myelofibrosis. However, currently available JAK inhibitors are myelosuppressive, leaving a critical unmet need for patients with anemia or those at risk of developing treatment-emergent anemia. Given momelotinib’s unique mechanism as an inhibitor of ACVR1 / ALK2 in addition to JAK1 and JAK2, we are excited by the potential for improved outcomes for myelofibrosis patients with this promising combination."

Deal Terms

Under the terms of the agreement, Sierra will pay AstraZeneca an upfront payment, as well as certain pre-determined development, regulatory and commercial milestones. In addition, Sierra will provide tiered royalty payments based on future commercial success. Sierra will be responsible for the initial Phase 2 trial execution and all future global development and commercialization activities. Additional deal terms will be included on a Form 8-K filed with the SEC.

Conference Call & Webcast

In connection with this announcement, Sierra will host a conference call and webcast on Thursday, August 5, 2021, at 5:00 pm ET. The call may be accessed by calling (844) 200-6205 (Toll-free in North America) or +44 208 0682 558 (International Dial-in) and entering the Conference ID number: 956684. The call will be webcast live and will be accessible through the Investor section of the Company’s website at www.SierraOncology.com. An archived replay of the webcast will be made available at the same location.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in Q1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.

On August 5, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter ended June 30, 2021 (Press release, Guardant Health, AUG 5, 2021, View Source [SID1234585950]
Recent Highlights

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Revenue of $92.1 million for the second quarter of 2021, an increase of 39% over the corresponding period of 2020
Reported 20,830 tests to clinical customers and 3,653 tests to biopharmaceutical customers in the second quarter of 2021, representing an increase of 52% and 30%, respectively, over the second quarter of 2020
Enrolled 10,000th patient in ECLIPSE trial and plans to launch a blood-based screening LDT in the first half of 2022
Expanded Guardant360 portfolio with launch of TissueNext and Response tests
Received FDA approvals for Guardant360 CDx as a companion diagnostic for LUMAKRAS and RYBREVANT in advanced non-small cell lung cancer
Appointed Chris Freeman as Chief Commercial Officer of Oncology
"I am proud of our team’s execution this quarter as we continued to expand our product portfolio and establish our solutions as best-in-class in cancer testing," said Helmy Eltoukhy, co-founder and CEO. "I am especially proud of the progress our clinical team has made running our ECLIPSE study during the pandemic and am excited to announce we have enrolled more than 10,000 patients to date. We are making great strides across our business to be a leader in cancer care and we are looking forward to continuing to make important progress in the second half of the year."

Second Quarter 2021 Financial Results

Revenue was $92.1 million for the three months ended June 30, 2021, a 39% increase from $66.3 million for the three months ended June 30, 2020. Precision oncology revenue grew 42% driven predominantly by an increase in clinical testing revenue which grew 54% over the prior year period. There were 20,830 clinical tests and 3,653 biopharmaceutical tests performed during the second quarter of 2021. Development services and other revenue increased 27% primarily due to the timing of project milestones related to the receipt of regulatory approval for two of our companion diagnostic programs during the three months ended June 30, 2021.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $62.2 million for the second quarter of 2021, an increase of $18.3 million from $43.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 68%, as compared to 66% for the corresponding prior year period.

Operating expenses were $159.8 million for the second quarter of 2021, as compared to $98.5 million for the corresponding prior year period, an increase of 62%. Non-GAAP operating expenses were $124.7 million for the second quarter of 2021, as compared to $72.9 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $97.6 million for the second quarter of 2021, as compared to $54.6 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.96 for the second quarter of 2021, as compared to $0.57 for the corresponding prior year period. Non-GAAP net loss was $61.4 million for the second quarter of 2021, as compared to $23.5 million for the corresponding prior year period. Non-GAAP net loss per share was $0.61 for the second quarter of 2021, as compared to $0.25 for the corresponding prior year period.

Adjusted EBITDA loss was $56.4 million for the second quarter of 2021, as compared to a $25.1 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.8 billion as of June 30, 2021.

2021 Guidance

Due to continued uncertainty around the global COVID pandemic, Guardant Health is maintaining its previous 2021 revenue guidance. The Company continues to expect full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020. Clinical volumes for 2021 are expected to be greater than 90,000 tests, growing at least 42% over 2020.

Webcast Information

Guardant Health will host a conference call to discuss the second quarter 2021 financial results after market close on Thursday, August 5, 2021 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

Non-GAAP Measures

Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On August 5, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will present at the 2021 Wedbush PacGrow Healthcare Conference on Wednesday, August 11th, 2021 at 9:10 a.m. ET (Press release, Scholar Rock, AUG 5, 2021, View Source [SID1234585949]).

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A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

On August 5, 2021 Ultivue, Inc. and Fluidigm Corporation (Nasdaq:FLDM) reported a co-marketing agreement in which the companies will offer customers a comprehensive portfolio of workflow solutions for biomarker discovery and drug development (Press release, Ultivue, AUG 5, 2021, View Source [SID1234585948]).

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Ultivue, a leader in advancing precision medicine solutions by accelerating tissue biomarker discovery and validation develops unique assays for use in multiplex immunofluorescence imaging and analysis. Its proprietary InSituPlex technology is designed for fast and comprehensive exploration of biologically-relevant markers combined with same slide-H&E analysis in precious tissue samples.

Fluidigm is a leader in high-parameter imaging for the clinical translational research and clinical testing markets. It’s Imaging Mass Cytometry (IMC) technology is designed for highly multiplexed targeted interrogation of tissue sections for 40 or more protein markers in one scan, with distinct non-overlapping signals from element-labeled antibodies detected simultaneously for each sub-micrometer pixel.

The collaboration provides reseachers with end-to-end service capability for clinical and translational work. For example, InSituPlex technology is well suited to identify regions of interest that may require downstream, deep profiling with IMC. Customer access to both technologies can improve the efficiency of drug discovery programs and, in translational research, enable patient stratification to triage cases that require further investigation.

"Imaging Mass Cytometry has become integral to the clinical translational research and clinical testing markets," said Chris Linthwaite, Fluidigm President and CEO. "Through Fluidigm Therapeutic Insights Services, we will offer our customers access to our technology as well as that of Ultivue, providing optimum imaging solutions for biomarker discovery and drug development."

"Ultivue is at the forefront of innovation to provide unique biological insights for our customers," said Mark Rees, Vice-President of Business Development at Ultivue. "Our InSituPlex technology offers valuable profiling of the tissue and expands the depth of information possible from a single section that is complementary to the high-parameter capabilities of Imaging Mass Cytometry. We believe this joint offering with Fluidigm will now provide researchers a seamless workflow enabling a far more efficient biomarker discovery and drug development process."

On August 5, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver and inflammatory diseases, reportedy that Yossi Borenstein, Shizim group CEO, was elected as an External Director at the Company’s recent annual general meeting (Press release, Can-Fite BioPharma, AUG 5, 2021, View Source [SID1234585947]).

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During the past 35 years, Mr. Yossi Bornstein has played key roles in the Israeli biomed industry. He was the General Manager of Bristol-Myers Squibb (Israel). Mr. Bornstein is the CEO and the founder of Shizim group, a life science holding company. He is the Founder of ShizimXL, International Medical Devices & ShizimVS, Digital Health innovation centers. He is the Chairman of GCP Clinical Studies Ltd., one of the top providers of clinical research services and educational programs in Israel. He served as the Biotechnology Committee Chairman of the United States-Israel Science & Technology Commission (the "USISTC"). Mr. Bornstein is the founder of ILSI – Israel Life Science Industry Organization and Founder of ITTN – Israel Tech Transfer Organization. He is a Co-Founder and director of Microbot Medical (NASDAQ: MBOT) and a Director of XACT Robotics.

"We welcome Yossi Borenstein as an External Director and trust that his skills will be highly valuable for Can-Fite," stated Can-Fite CEO Pnina Fishman.