Guardant Health Reports Third Quarter 2018 Financial Results

On November 19, 2018 Guardant Health, Inc. (Nasdaq:GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the third quarter ended September 30, 2018 (Press release, Guardant Health, NOV 19, 2018, View Source [SID1234531532]).

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Recent Highlights

Revenues of $21.7 million for the third quarter of 2018, representing a 95% increase over the third quarter of 2017

Reported 7,027 tests to clinical customers and 2,505 tests to biopharmaceutical customers in the third quarter, representing increases of 14% and 67% respectively, over the third quarter 2017

Lung cancer study published in JAMA Oncology demonstrated Guardant360 outperformed tissue biopsy alone in identification of targetable mutations

Awarded Medicare coverage for the Guardant360 assay in non-small cell lung cancer through a local coverage determination from Palmetto GBA, a Medicare Administrative Contractor; successfully received first payment

Completed initial public offering, raising approximately $249.5 million of net proceeds, after underwriting fees and other expenses
"Our third quarter accomplishments reflect the ongoing strength of our business," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We are continuing to build proof points for a blood-first paradigm ahead of traditional tissue genotyping, as demonstrated by the study from the University of Pennsylvania which was recently published in JAMA Oncology."
"In addition, we are pleased with the successful completion of our IPO," continued Dr. Eltoukhy. "We are grateful for the support of our investors who participated in the offering, and we are focused on the creation of long-term shareholder value through unprecedented access to cancer’s molecular information throughout all stages of the disease."
Third Quarter 2018 Financial Results
Revenue was $21.7 million in the three months ended September 30, 2018, a 95% increase from $11.1 million in the three months ended September 30, 2017. Precision oncology revenue increased 78% driven by higher testing volume and increases in revenue per test. Tests for clinical customers increased 14% (after excluding tests in the third quarter of 2017 from a customer that began processing tests in-house in March 2018 based on a joint development agreement) and tests for biopharmaceutical customers increased 67%.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $11.6 million for the third quarter of 2018, an increase of $9.1 million from $2.5 million in the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 53.7%, as compared to 22.2% in the corresponding prior year period.
Operating expenses were $35.8 million for the third quarter of 2018, as compared to $31.1 million in the corresponding prior year period, an increase of 15%.
Net loss attributable to Guardant Health, Inc. common stockholders was $24.5 million in the third quarter of 2018, as compared to $33.3 million in the corresponding period of the prior year. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.94 in the third quarter of 2018, as compared to $2.76 in the corresponding period of the prior year.
Cash, cash equivalents and marketable securities were $274.3 million as of September 30, 2018. In October 2018, Guardant completed an initial public offering, raising approximately $249.5 million net of underwriting fees and other expenses.
2018 Financial Guidance
Guardant Health expects full year 2018 revenue to be in the range of $82.0 million to $84.0 million.
Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the third quarter 2018 financial results after market close on Monday, November 19, 2018 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 9156645). The webcast can be accessed at View Source

Sensei Biotherapeutics to Present at the 30th Annual Piper Jaffray Healthcare Conference

On November 19, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics, will present a company overview at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 1:30 p.m. ET in New York, NY (Press release, Sensei Biotherapeutics, NOV 19, 2018, View Source [SID1234531446]).

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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

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RXi Pharmaceuticals Corporation Changes Name to Phio Pharmaceuticals Corp.

On November 19, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that its corporate name change from RXi Pharmaceuticals Corporation to Phio Pharmaceuticals Corp. became effective at 12:01 a.m. Eastern Time today, November 19, 2018 (Press release, RXi Pharmaceuticals, NOV 19, 2018, View Source [SID1234531476]). In connection with the name change, the Company’s shares of common stock will trade under a new ticker symbol, "PHIO," and a new CUSIP number, 71880W204, at the market open today. In addition, the Company’s warrants that are currently trading on the Nasdaq Capital Market will begin trading under the new ticker symbol, "PHIOW," and new CUSIP number, 71880W105. Concurrently, the Company is launching a new website, www.phiopharma.com.

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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

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Said Dr. Gerrit Dispersyn, President & COO of Phio Pharmaceuticals, "The name change from RXi Pharmaceuticals to Phio Pharmaceuticals reflects the completion of our Company’s transition from a platform company to one that is fully committed to develop groundbreaking immuno-oncology therapeutics based on our self-delivering RNAi platform."

OncoCyte Corporation to Present at the Piper Jaffray 30th Annual Health Care Conference

On November 19, 2018 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported that the Company will provide a corporate overview at the Piper Jaffray 30th Annual Health Care Conference, being held November 27-29, 2018 at the Lotte New York Palace Hotel in New York, NY (Press release, Oncocyte, NOV 19, 2018, View Source [SID1234531492]).

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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

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OncoCyte Corporation Presentation Details:

Date: Thursday, November 29
Time: 10:00am Eastern Time
Location: Lotte New York Palace Hotel
Webcast: View Source;tp_key=48b258fde4

City of Hope Doctors Present New Research on CAR T Cell Therapy, Bone Marrow Transplants and Other Treatments for Blood Cancers

On November 19, 2018 City of Hope reported that it will present data on new findings on immunotherapies, including CAR T cell therapy, bone marrow transplants and other treatments for blood cancers, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting Dec. 1-4 in San Diego (Press release, City of Hope, NOV 19, 2018, View Source [SID1234531447]).

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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

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City of Hope is addressing some of the hardest-to-treat cancers by accelerating innovative clinical research approaches. The institution was a pioneer in bone marrow and stem cell transplants — and the transplantation program is now one of the largest, most successful programs of its kind in the U.S. Its CAR T therapy program was the first to treat patients with CAR T cells targeting the IL13Rα2 antigen in glioblastomas, and the first to offer CAR T trials targeting CD123 in acute myeloid leukemia.

City of Hope doctors will make special presentations at the ASH (Free ASH Whitepaper) conference. Joseph Alvarnas, vice president for government affairs and associate clinical professor of hematology and hematopoietic cell transplantation, will chair an ASH (Free ASH Whitepaper) Practice Partnership Lunch titled "How to Incorporate Palliative Care Into Practice: Addressing Barriers and Solutions," which addresses how patients with hematologic malignancies often have difficulty accessing high-quality symptom management and palliative care because of preconceived perceptions as well as limited reimbursement, and discusses solutions. The lunch takes place Sunday, Dec. 2, 2018, 11:15 a.m.-12:30 p.m., in the Marina Ballroom G (Marriott Marquis San Diego Marina).

City of Hope researchers will also make presentations on the following data:

610: CD19-CAR Therapy Using Naive/Memory or Central Memory T Cells Integrated into the Autologous Stem Cell Transplant Regimen for Patients with B-NHL
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 7:45 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Leslie Popplewell, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

965: The Cerebroventricular Environment Reprograms Locally Infused CAR T Cells for Superior Activity Against Both CNS and Systemic B Cell Lymphoma
Type: Oral
Session: 703. Adoptive Immunotherapy: Preclinical Studies to Improve Safety and Efficacy of CAR-T Cells
Session Date and Time: Monday, Dec. 3, 2018: 5:30 p.m.
Location: San Diego Ballroom B (Marriott Marquis San Diego Marina)
Presenter: Xiuli Wang, Ph.D., research professor, Department of Hematology & Hematopoietic Cell Transplantation

399 Mosunetuzumab, a Full-Length Bispecific CD20/CD3 Antibody, Displays Clinical Activity in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL): Interim Safety and Efficacy Results from a Phase 1 Study
Type: Oral
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)
Session Date and Time: Sunday, Dec. 2, 2018: 12:30 p.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Elizabeth Lihua Budde, M.D., Ph.D., assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

300 Rapid MRD-Negative Responses in Patients with Relapsed/Refractory CLL Treated with Liso-Cel, a CD19-Directed CAR T-Cell Product: Preliminary Results from Transcend CLL 004, a Phase 1/2 Study Including Patients with High-Risk Disease Previously Treated with Ibrutinib
Type: Oral
Session: 642. CLL: Therapy, excluding Transplantation
Session Date and Time: Sunday, Dec. 2, 2018: 8:45 a.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Tanya Siddiqi, assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

620: Muscle Depletion Is an Important and Clinically Relevant Predictor of Outcomes after Autologous Hematopoietic Cell Transplantation
Type: Oral
Session: 904. Outcomes Research—Malignant Conditions: Outcomes in Lymphoid Malignancies and Stem Cell Transplant
Session Date and Time: Monday, Dec. 3, 2018: 7:15 a.m.
Location: Room 24B (San Diego Convention Center)
Presenter: Alex Iukuridze, clinical research assistant, Department of Population Sciences

611: Phase I Study of Yttrium-90 Labeled ANTI-CD25 (aTac) Monoclonal Antibody PLUS BEAM for Autologous Hematopoietic CELL Transplantation (AHCT) in Patients with Mature T-CELL NON-Hodgkin Lymphoma, the "a-TAC-BEAM Regimen"
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 8 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Jasmine M. Zain, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation, and director, T cell Lymphoma Program

4016 Adult Patients with ALL Treated with CD62L+ T Naïve/Memory-Enriched T Cells Expressing a CD19-CAR Mediate Potent Antitumor Activity with a Low Toxicity Profile
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Samer K. Khaled, M.D. assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

2181: Clinical Outcomes of MDS Patients Who Were Allogeneic Hematopoietic Stem Cell Transplant Candidates but Did Not Proceed with Transplantation
Type: Poster
Session: 732. Clinical Allogeneic Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Rohan Gupta, clinical resident/fellow, Department of Medical Oncology & Therapeutics Research

1411: Novel BAFF-R CAR T-Cell Therapy for CD19 Antigen-Loss Relapsed B Cell Tumors
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Hong Qin, Ph.D., associate research professor, Department of Hematology & Hematopoietic Cell Transplantation

3967: Disease Burden Subgroup Analysis of Health-Related Quality of Life of Blinatumomab Versus Standard-of-Care Chemotherapy in Patients with Relapsed or Refractory Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER)
Type: Poster
Session: 612. Acute Lymphoblastic Leukemia
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Anthony Stein, M.D., co-director, Gehr Family Center for Leukemia Research, clinical professor, Department of Hematology & Hematopoietic Cell Transplantation