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ViewRay Reports Second Quarter 2021 Results

On August 5, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the second quarter ended June 30, 2021 (Press release, ViewRay, AUG 5, 2021, View Source [SID1234586033]).

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Second Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $37.9 million, compared to four new orders totaling $24.6 million in the second quarter of 2020.
Total backlog increased to $278.4 million as of June 30, 2021, compared to $232.2 million as of June 30, 2020.
Total revenue of $15.0 million primarily from two revenue units, compared to $14.2 million primarily from two revenue units in the second quarter of 2020.
Cash usage in the second quarter of 2021 was approximately $15 million compared to approximately $11 million in the second quarter of 2020.
Cash and cash equivalents were $166.9 million as of June 30, 2021.
"Our second quarter performance is a solid step forward and reflects progress on our commercial, innovation, and clinical pipelines. Our team has executed very well in an environment that continues to be challenging," said Scott Drake, President and CEO. "We are well positioned to drive further growth, therapy adoption, and extend our innovation lead."

Three Months Ended June 30, 2021 Financial Results

Total revenue for the three months ended June 30, 2021 was $15.0 million compared to $14.2 million for the same period last year.

Total gross profit (loss) for the three months ended June 30, 2021 was ($1.7) million, compared to ($1.0) million for the same period last year.

Total operating expenses for the three months ended June 30, 2021 were $24.8 million, compared to $24.5 million for the same period last year.

Net loss for the three months ended June 30, 2021 was $31.0 million, or $0.19 per share, compared to $26.2 million, or $0.18 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $166.9 million at June 30, 2021.

Six Months Ended June 30, 2020 Financial Results:

Total revenue for the six months ended June 30, 2021 was $30.6 million compared to $28.5 million for the same period last year.

Total gross profit (loss) for the six months ended June 30, 2021 was $(1.4) million, compared to $(3.1) million for the same period last year.

Total operating expenses for the six months ended June 30, 2021 were $49.8 million, compared to $52.5 million for the same period last year.

Net loss for the six months ended June 30, 2021 was $57.7 million, or $0.36 per share, compared to $53.7 million, or $0.36 per share, for the same period last year.

Financial Guidance
For the full year 2021, ViewRay anticipates total revenue to be in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.

Conference Call and Webcast
ViewRay will hold a conference call to discuss results on Thursday, August 5, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 8473598. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8473598.

Fusion Pharmaceuticals to Participate in the 2021 Wedbush PacGrow Healthcare Virtual Conference

On August 5, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will participate in the "Hot Topic – Radiopharmaceuticals" panel discussion at the 2021 Wedbush PacGrow Healthcare Virtual Conference on Wednesday, August 11, 2021 at 4:05pm EDT (Press release, Fusion Pharmaceuticals, AUG 5, 2021, View Source [SID1234586032]). Participating in the panel on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

Synthetic Biologics Reports Second Quarter 2021 Operational Highlights and Financial Results; Conference Call to be Held Today at 4:30 PM ET

On August 5, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal ("GI") diseases in areas of high unmet need, reported financial results for the second quarter ended June 30, 2021 (Press release, Synthetic Biologics, AUG 5, 2021, View Source [SID1234586031]).

Recent Developments:

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose ("SAD") clinical trial of SYN-020 intestinal alkaline phosphatase ("IAP")
Continuing enrollment in the Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant ("HCT") recipients
Current cash position of approximately $74.3 million
Current cash runway expected to provide funding to complete Phase 1b/2a clinical trial of SYN-004, clinical trials of SYN-020 through proof-of-concept, and other key milestones into 2023
Anticipated Milestones:

Expect to commence second Phase 1 multiple-ascending dose ("MAD") clinical trial of SYN-020 during Q3 2021; topline data anticipated during Q2 2022
Topline data readout from the first antibiotic cohort of the SYN-004 Phase 1b/2a clinical trial is expected during Q4 2021
"During the second quarter, we remained focused on the advancement of our portfolio of gastrointestinal and microbiome-focused clinical programs," said Steven A. Shallcross, Chief Executive Officer of Synthetic Biologics. "We were pleased to complete patient dosing and observation in the Phase 1 SAD clinical trial of SYN-020 intestinal alkaline phosphatase with preliminary results demonstrating that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to SYN-020. Looking ahead, we intend to commence a second Phase 1 MAD clinical trial of SYN-020 in healthy adult volunteers during the third quarter of 2021 with topline results expected during the second quarter of 2022. Both the Phase 1 SAD and MAD studies are designed to support the advancement of SYN-020 in multiple potential therapeutic indications, including celiac disease, nonalcoholic fatty liver disease ("NAFLD"), radiation enteritis, and age-related metabolic and inflammatory diseases."

Mr. Shallcross continued, "Patient screening and enrollment in the SYN-004 Phase 1b/2a clinical trial in allogeneic HCT recipients remains ongoing at the Washington University School of Medicine in St. Louis ("Washington University"). At this time, enrollment is proceeding as expected and we anticipate announcing topline results from this first of three antibiotic cohorts during the fourth quarter of 2021. We believe SYN-004 has the potential to significantly improve outcomes for allogeneic HCT recipients by preventing downstream complications often caused by disruption of the gut microbiome by intravenous ("IV") beta-lactam antibiotics following conditioning therapy. We are very excited about the potential for our portfolio of clinical development programs to be long-term value drivers for our Company and look forward to sharing important updates as they become available."

Clinical Development and Operational Update

Announced completion of patient dosing and observation in the Phase 1, open label, single-ascending dose clinical trial of SYN-020
The Phase 1 SAD study enrolled 24 healthy adult volunteers into four cohorts with SYN-020 given orally as single doses ranging from 5 mg to 150 mg.
Analyses of preliminary data demonstrated that SYN-020 maintained a favorable safety profile, was well tolerated at all dose levels, and no adverse events were attributed to the study drug. No serious adverse events were reported.
A second Phase 1 clinical trial evaluating multiple-ascending doses of SYN-020 in healthy volunteers is expected to commence during the third quarter of 2021. Topline data are anticipated during the second quarter of 2022, pandemic conditions permitting.
Both studies are intended to support the development of SYN-020 in multiple potential clinical indications including celiac disease, NAFLD, radiation enteritis, as well as indications supported by the Company’s collaboration with Massachusetts General Hospital.
Enrollment in the Company’s Phase 1b/2a clinical trial of SYN-004 in allogeneic HCT recipients for the prevention of acute graft-versus-host-disease ("aGVHD") remains ongoing
The Phase 1b/2a clinical trial comprises a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 in up to 36 evaluable adult allogeneic HCT recipients.
The goal of this clinical trial is to evaluate the safety, tolerability, and potential absorption into the systemic circulation (if any) of oral SYN-004 administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever.
Study participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 and four will receive placebo.
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee ("DSMC"), which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic.
A topline data readout for the first antibiotic cohort is anticipated during the fourth quarter of 2021, pandemic conditions permitting.
Received notification from the NYSE American that the Company had regained compliance with all of the continued listing standards set forth in Part 10, Section 1003 of the NYSE American Company Guide (the "Company Guide") relating to the Exchange’s continued listing requirements.
Quarter Ended June 30, 2021 Financial Results

General and administrative expenses decreased by 2% to approximately $1.26 million for the three months ended June 30, 2021, from approximately $1.29 million for the three months ended June 30, 2020. This decrease is primarily due to lower legal costs and vacation expense offset by higher insurance costs, audit fees and registration fees. The charge related to stock-based compensation expense was $83,000 for the three months ended June 30, 2021, compared to $67,000 for the three months ended June 30, 2020.

Research and development expenses increased by 21% to approximately $1.9 million for the three months ended June 30, 2021, from approximately $1.6 million for the three months ended June 30, 2020. This increase is primarily the result of increased clinical trial expenses as we began dosing patients in the Phase 1b/2a clinical trial of SYN-004 and Phase 1 SAD clinical trial of SYN-020 during the three months ended June 30, 2021, offset by lower indirect program costs for the three months ended June 30, 2021, including salary and related expense reductions, a decrease in manufacturing costs for SYN-020 and market research. In addition, as a result of the global COVID-19 pandemic, our clinical development partner (Washington University) reduced their operating capacity during 2020 to include only essential activities as part of their pandemic response, which delayed the start of our clinical trial until 2021. We anticipate research and development expense to increase as our ongoing clinical trials continue to enroll patients. The charge related to stock-based compensation expense was $19,000 for the three months ended June 30, 2021, compared to $19,000 related to stock-based compensation expense for the three months ended June 30, 2020.

Other income was $2,000 for the three months ended June 30, 2021, compared to other income of $6,000 for the three months ended June 30, 2020. Other income for the three months ended June 30, 2021 and 2020 is primarily comprised of interest income.

Cash and cash equivalents as of June 30, 2021 totaled $74.3 million, an increase of $68.1 million from December 31, 2020.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, August 5, 2021, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source , for 90 days after the call.

Updated Overall Survival Data and Biomarker Results from Sintilimab ORIENT-11 Study in First-Line Nonsquamous Non-Small Cell Lung Cancer Published in the Journal of Thoracic Oncology

On August 5, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company (NYSE: LLY) reported new and updated data from the ORIENT-11 study demonstrating a sustained survival benefit of sintilimab in combination with pemetrexed and platinum chemotherapy in the first-line treatment of patients with nonsquamous non-small cell lung cancer (Press release, Innovent Biologics, AUG 5, 2021, View Source [SID1234586030]). In addition, biomarker results from the trial provide important insights for patients with high major histocompatibility complex (MHC) class-II expression. These findings were published today in the Journal of Thoracic Oncology. (https://www.sciencedirect.com/science/article/pii/S1556086421023303)

In August 2020, interim analysis data from ORIENT-11 were released in an oral presentation at the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium. These interim data were simultaneously published online by the Journal of Thoracic Oncology.

ORIENT-11 is a randomized, double-blind Phase 3 clinical trial evaluating sintilimab in combination with pemetrexed and platinum chemotherapy compared to placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for locally advanced or metastatic nonsquamous NSCLC without sensitizing EGFR mutations or ALK rearrangements. The Journal of Thoracic Oncology manuscript discloses, as of January 15, 2021, with a median follow-up of 22.9 months, the median overall survival (OS) of patients receiving the sintilimab combination was not yet reached. The sintilimab combination demonstrated a sustainable OS benefit (HR=0.60, 95% CI: 0.45-0.79; p=0.0003), and the median OS for those receiving the placebo combination was 16.8 months.

Whole transcriptome sequencing of baseline tumor samples was performed to probe the predictive and correlative biomarkers, showing that high or medium immune cell infiltration was strongly associated with improved progression-free survival (PFS) in the sintilimab combination group. In particular, high MHC class-II presentation pathway expression was significantly correlated with prolonged PFS (HR=0.32, 95% CI: 0.19-0.54; p<0.0001) and OS (HR=0.36, 95% CI: 0.20-0.64; p=0.0005) in the sintilimab combination group.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 and the corresponding author of the manuscript, stated, "Sintilimab in combination with pemetrexed and platinum chemotherapy demonstrated a sustainable survival benefit after long-term follow-up in the ORIENT-11 study. These data showed that this sintilimab combination should be further evaluated as front-line therapy for patients with previously untreated, locally advanced or metastatic nonsquamous non-small cell lung cancer without EGFR or ALK genomic tumor aberrations."

Dr. Wei Xu, Vice President of Translational Medicine of Innovent and co- corresponding author of the manuscript, stated, "Immunotherapy based on PD-1 and PD-L1 antibodies has revolutionized clinical practice of treating non-small cell lung cancer. However, the precise patient population who will benefit from immunotherapy-chemotherapy combination treatment is still unclear. We explored the gene expression profile in the tumor microenvironment and found that the infiltration of antigen-presenting cells and high expression of the MHC-II antigen presentation pathway correlated with improved outcomes in patients who received the sintilimab-pemetrexed-platinum chemotherapy combination. This finding contributes to a better understanding of the mechanism of action of the immunotherapy-chemotherapy combination which could help inform selection of suitable patients for future sintilimab studies. Publication of this study in the Journal of Thoracic Oncology is a recognition of the important work by this research team and we will continue to explore new areas in immuno-oncology, with the goal of identifying additional novel approaches to treat cancer in clinical practice."

Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "We’re excited to see that the results of ORIENT-11 show sintilimab in combination with pemetrexed and platinum chemotherapy can bring an overall survival benefit to patients with nonsquamous non-small cell lung cancer in the first-line treatment setting. Also, research of the tumor microenvironment is helping scientists find suitable biomarkers as potential targets for cancer treatment. These ORIENT-11 biomarker results published in the Journal of Thoracic Oncology will help us further understand the mechanism of action of this immunotherapy-based combination in order to identify patients who are more likely to respond to treatment."

About the ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating the efficacy and safety of sintilimab or placebo in combination with pemetrexed and platinum chemotherapy as a first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with pemetrexed and platinum chemotherapy every three weeks for up to four cycles, followed by either sintilimab injection or placebo plus pemetrexed maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About Lung Cancer

Globally, lung cancer is the leading cause of cancer death, killing nearly 1.8 million people worldwide each year. In the U.S., lung cancer is the second most common cancer (not counting skin cancer) and the leading cause of cancer death, responsible for nearly 25 percent of all cancer deaths – more than those from colorectal, breast and prostate cancers combined. Non-small cell lung cancer (NSCLC) accounts for approximately 85 percent of all lung cancers, and about 70 percent of those with NSCLC have the nonsquamous subtype. Fifty percent of NSCLC patients present with advanced or metastatic disease at diagnosis.

About Sintilimab

Sintilimab, marketed as TYVYT (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.

In China, sintilimab has been approved for four indications, including:

The treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy
In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of nonsquamous non-small cell lung cancer
In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer
In combination with BYVASDA (bevacizumab biosimilar injection) for the first-line treatment of hepatocellular carcinoma
Additionally, Innovent currently has a regulatory submission under review in China for sintilimab for the second-line treatment of squamous non-small cell lung cancer.

Innovent also has two clinical studies of sintilimab that have met their primary endpoints:

In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma
The second-line treatment of esophageal squamous cell carcinoma
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.

Sintilimab was included in China’s National Reimbursement Drug List (NRDL) in 2019 as the first PD-1 inhibitor and the only PD-1 included in the list in that year.

10-Q – Quarterly report [Sections 13 or 15(d)]

BeiGene has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .