On August 5, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported financial results for the second quarter ended June 30, 2021 and provided operational highlights (Press release, Arcus Biosciences, AUG 5, 2021, View Source [SID1234585952]). Management will host a conference call today, August 5, 2021 beginning at 1:30 pm PT/ 4:30 pm ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have made significant progress advancing our portfolio and partnerships in the first half of 2021," said Terry Rosen, Ph.D., CEO. "We generated additional clinical data for four of our clinical-stage molecules, across trials in lung, colon, prostate, and pancreatic cancers, that continue to support our ongoing randomized studies. We also advanced our Fc-enabled anti-TIGIT antibody into a Phase 1 study and selected our HIF-2α small molecule to be our sixth clinical-stage molecule, anticipated to enter the clinic by the end of the year. With over $800 million of cash and investments as of the end of the second quarter, and our partnership with Gilead, we are confident we can address and pursue the immense need in these patient populations and the corresponding magnitude of the market opportunities."

Anti-TIGIT Program
Domvanalimab (Fc-silent anti-TIGIT antibody)
Recent Highlights:

Arcus continues to enroll our ARC-7 study and ARC-10 Phase 3 registrational study as planned, based on encouraging results from the first interim analysis from ARC-7, a randomized, three-arm Phase 2 trial evaluating domvanalimab (dom) + zimberelimab (zim) vs. zim vs. dom + zim + etrumadenant (etruma) in first-line PD-L1≥50%, metastatic non-small cell lung cancer (NSCLC).
Data from the zim arm demonstrated activity similar to that of other marketed anti-PD-1 antibodies in the setting.
Data from the doublet and triplet arms demonstrated promising antitumor activity, and the triplet arm performed particularly well across multiple measures, including objective response rate (ORR) and depth of response. More mature data will enable us to better assess the contributions of each molecule, dom and etruma.
At the time of data cut off, no unexpected safety signals were observed.
Based on this dataset, Arcus and Gilead will continue preparations for additional Phase 3 studies of dom-based combinations. We will also explore other development opportunities for the triplet.
Upcoming Milestones:

Results from the interim analysis for ARC-7 are expected to be submitted later this year for a presentation in 4Q21 or in 1H22.
We anticipate an opt-in trigger decision by Gilead for our anti-TIGIT program by year-end 2021.
Initiation of PACIFIC-8, in collaboration with AstraZeneca, anticipated to start in 4Q21. PACIFIC-8 is a registrational trial designed to evaluate dom and durvalumab in Stage 3 NSCLC.
AB308 (Fc-enabled anti-TIGIT antibody)
Recent Highlights:

Recommended dose for expansion (RDE) selected in the Phase 1/1b ARC-12 study evaluating AB308 plus zim in advanced malignancies. This study is designed to efficiently establish the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AB308 + zim to facilitate advancement into a late-stage trial.
Upcoming Milestones:

Initiation of five expansion cohorts in the Phase 1b portion of the study is expected in the third quarter.
Quemliclustat (also referred to as AB680; CD73 inhibitor)
Recent Highlights:

Completed enrollment in the expansion cohort of our Phase 1/1b ARC-8 study of quemliclustat (quemli) plus chemotherapy and zim in patients with first-line metastatic pancreatic ductal adenocarcinoma. The data continue to look promising, particularly the safety profile of the combination and the high percentage of patients that experienced tumor shrinkage.
Currently enrolling the randomized portion of this study which is comparing quemli + zim + gemcitabine (G)/nab-paclitaxel (NP) vs. quemli + G/NP to inform our Phase 3 registrational design.
Upcoming Milestones:

Opening of a new arm to evaluate quemli in second-line pancreatic cancer is expected in 3Q21 based on encouraging first-line results and high interest from investigators.
Updated data from the dose-escalation and dose-expansion cohorts of ARC-8 study are expected to be released in the Fall.
Completion of enrollment of the 90-patient randomized portion of the ARC-8 study is expected by year-end 2021. We expect to present initial randomized data in mid-2022 and anticipate utilizing data from the randomization portion of the study combined with data from the dose escalation and expansion cohorts to discuss the path to registration with health authorities.
Etrumadenant (A2a/A2b adenosine receptor antagonist)
Recent Highlights:

Presented initial Phase 1b data in metastatic castrate-resistant prostate cancer (mCRPC) from ARC-6 at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The data from the Stage 1 portion of the etruma + zim + docetaxel cohort in patients with 2L+ mCRPC showed the etruma-based combination was well tolerated and demonstrated promising clinical activity in patients with advanced disease who had progressed on prior treatments.
Demonstrated preliminary activity with etruma in combination with dom plus zim (triplet arm) in ARC-7. The clinical activity in the triplet arm is the first reported on for an anti-TIGIT and adenosine receptor antagonist combination and potentially provides a novel and differentiated therapy for this patient population.
Upcoming Milestones:

Initial randomized data, including ORR and PFS, from our ARC-4 study in EGFR+ NSCLC cancer is expected to be presented in 1H22. ARC-4 is a randomized Phase 1b study evaluating etruma + zim + chemotherapy vs. zim + chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory NSCLC.
Initial randomized data from our ARC-6 study in prostate cancer is expected to be presented in 2022. ARC-6 is a Phase 1b/2 randomized study evaluating the efficacy and safety of etruma-based treatment combinations.
HIF-2α inhibitor Program
Recent Highlights:

Selected AB521 as the lead clinical candidate for our HIF-2α inhibitor program. AB521 has demonstrated excellent potency, selectivity, biological activity and pharmacokinetic properties in preclinical studies.
Upcoming Milestones:

Initiation of clinical development for our HIF-2α inhibitor, AB521, is anticipated to occur in 4Q21. This first study is expected to be in healthy volunteers to expeditiously characterize the pharmacokinetic and safety profile of AB521 and to identify the starting dose for the Phase 1/1b study in oncology indications, which is anticipated to begin in 1H22.
Corporate
Recent Highlights:

Appointed Nicole Lambert to our Board of Directors. Ms. Lambert is currently President of Myriad Genetic Laboratories and has extensive experience in the healthcare industry spanning more than 20 years, including expertise successfully growing and leading global commercial organizations. She will be a great asset to Arcus, and we are thrilled to welcome her to our team, as we continue to advance our registrational programs.
Upcoming Milestones:

Initiation of a Phase 1 platform study, by partner Taiho, is expected in 3Q21. Taiho filed an IND in Japan in 2Q21 to evaluate zim in intra-portfolio combinations targeting oncology indications.
Financial Results for the Second Quarter 2021

Cash, cash equivalents and investments were $805.1 million as of June 30, 2021, compared to $735.1 million as of December 31, 2020. The increase was primarily due to gross proceeds of $220.4 million received upon the closing of the private placement of common stock under the Amended and Restated Stock Purchase Agreement with Gilead in February 2021, partially offset by cash utilized for our operations. We expect cash, cash equivalents and marketable securities on-hand to be sufficient to fund operations at least through 2023.
Revenues: Collaboration and license revenues were $9.5 million for the three months ended June 30, 2021, compared to $1.8 million for the same period in 2020. In the three months ended June 30, 2021, we recognized $7.7 million in collaboration revenues related to Gilead’s ongoing rights to access our research and development pipeline in accordance with the Gilead Collaboration Agreement, as well as $1.8 million under the Taiho Agreement. In the three months ended June 30, 2020, we recognized $1.8 million under the Taiho Agreement. Collaboration and license revenues were $18.9 million for the six months ended June 30, 2021, compared to $3.5 million for the same period in 2020.
R&D Expenses: Research and development expenses were $68.8 million for the three months ended June 30, 2021, compared to $35.7 million for the same period in 2020. The increase was primarily due to increases in employee compensation costs driven by increasing headcount and 2021 stock awards. Of the total change in employee compensation costs, approximately $4.6 million consists of increased non-cash stock-based compensation. Clinical and manufacturing costs increased as well due to the increased number of clinical programs and studies compared to the same quarter in the prior year. Lab supplies and equipment, clinical consulting, and office and facilities expense all increased as we continued to grow. The overall increase in research and development expenses is partially offset by a decrease in milestone expense incurred and an increase in reimbursements from collaboration partners. Research and development expenses were $135.2 million for the six months ended June 30, 2021, compared to $58.8 million for the same period in 2020.
G&A Expenses: General and administrative expenses were $16.8 million for the three months ended June 30, 2021, compared to $11.4 million for the same period in 2020. The increase in expense was due to increases in employee compensation costs driven by increasing headcount and 2021 stock awards. Of the total change in employee compensation costs, approximately $4.3 million consists of increased non-cash stock-based compensation. We also incurred additional facilities expense due to our expanding headcount and office space. The overall increase was partially offset by decreases in legal, accounting and other consulting expenses. In 2020, we incurred significant costs related to our transaction with Gilead and other corporate development activities. General and administrative expenses were $32.6 million for the six months ended June 30, 2021, compared to $18.4 million for the same period in 2020.
Net Loss: Net loss was $76.0 million for the three months ended June 30, 2021, compared to a net loss of $45.1 million for the same period in the prior year. Net loss was $148.6 million for the six months ended June 30, 2021, compared to $72.8 million for the same period in 2020.
Conference Call

Management will host a conference call today, August 5, 2021 to discuss second quarter 2021 financial results and recent corporate highlights. The call will begin at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the conference call may do so by dialing (844) 200-6205 in the U.S. or +44 208 0682 558 internationally, using Conference ID: 152804. In addition, the live webcast and any accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for at least two weeks following the live event.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."