OPKO Health to Announce First Quarter 2018 Financial Results on May 8, 2018

On May 2, 2018 OPKO Health, Inc.(NASDAQ:OPK) reported its operating and financial results for the three months ended March 31, 2018 after the close of the U.S. financial markets on Tuesday, May 8, 2018 OPKO Health, Inc.(NASDAQ:OPK) plans to announce its operating and financial results for the three months ended March 31, 2018 after the close of the U.S. financial markets on Tuesday, May 8, 2018.

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!

OPKO’s senior management will provide a business update and discuss its financial results in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time on Tuesday, May 8, 2018.

Conference Call & Webcast Information

WHEN: Tuesday, May 8, 2018 at 4:30 p.m. Eastern time.
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
PASSCODE: 5976529
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning May 8, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 5976529. The replay can be accessed for a period of time on OPKO’s website at View Source..

OPKO’s senior management will provide a business update and discuss its financial results in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time on Tuesday, May 8, 2018.

Conference Call & Webcast Information

WHEN: Tuesday, May 8, 2018 at 4:30 p.m. Eastern time.
DOMESTIC DIAL-IN: (866) 634-2258
INTERNATIONAL DIAL-IN: (330) 863-3454
PASSCODE: 5976529
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning May 8, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 5976529. The replay can be accessed for a period of time on OPKO’s website at View Source.

Novavax to Host Conference Call to Discuss First Quarter Financial Results on May 9, 2018

On May 2, 2018 Novavax, Inc. (Nasdaq:NVAX) reported it will report its first quarter 2018 financial and operating results following the close of U.S. financial markets on Wednesday, May 9, 2018 (Press release, Novavax, MAY 2, 2018, http://ir.novavax.com/news-releases/news-release-details/novavax-host-conference-call-discuss-first-quarter-financial-1 [SID1234525990]).

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!

Conference call details are as follows:

Date: May 9, 2018
Time: 4:30 p.m. U.S. Eastern Time (ET)
Dial-in number: (877) 212-6076 (Domestic) or (707) 287-9331 (International)
Passcode: 3687883
Webcast: www.novavax.com, "Investors"/ "Events"

Conference call and webcast replay:

Dates: Starting at 7:30 p.m. ET, May 9, 2018 until
7:30 p.m. ET May 16, 2018
Dial-in number: (855) 859-2056 (Domestic) or (404) 537-3406 (International)
Passcode: 3687883
Webcast: www.novavax.com, "Investors"/ "Events", until August 9, 2017

Foundation Medicine Announces 2018 First Quarter Results and Recent Highlights

On May 2, 2018 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the first quarter ended March 31, 2018 (Press release, Foundation Medicine, MAY 2, 2018, View Source [SID1234525989]). Highlights for the quarter included:

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!

Posted revenue of $52.8 million, 101% year-over-year growth;
Reported 21,861 clinical tests, 57% year-over-year growth;
Achieved broad Medicare coverage through a final National Coverage Determination (NCD) from the Centers for Medicare and Medicaid Services (CMS) for FoundationOne CDx across all solid tumors for eligible stage III and stage IV cancer patients;
Launched FoundationOne CDx, the first FDA approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics;
Announced that an expanded version of FoundationACT, which will include an expanded gene set and genomic biomarkers for microsatellite instability (MSI) and blood tumor mutational burden (bTMB), was granted Breakthrough Device designation (formerly Expedited Access Pathway) by the FDA;
Announced a comprehensive gene expression profiling (GEP) program which leverages deep expertise in DNA and RNA sequencing to support precision oncology clinical research and development and identification of novel genomic and expression-based biomarkers for personalized cancer therapies;
Partnered with Chugai Pharmaceutical Co. to commercialize the company’s CGP tests in Japan, including the filing by Chugai of an application with the Ministry of Health, Labour and Welfare (MHLW) for approval of FoundationOne CDx in Japan;
Announced a partnership with Roche and DIAN Diagnostics, a leading NGS diagnostics laboratory in China, to integrate Foundation Medicine’s CGP assays into clinical patient care in mainland China; and
Published 22 peer-reviewed manuscripts in medical and scientific journals and presented 35 podium talks and posters at scientific and medical meetings.
"Foundation Medicine delivered another strong quarter. Compared to the same quarter last year, we doubled revenue over last year and reported record clinical volume," stated Troy Cox, chief executive officer of Foundation Medicine. "Just four months into the year, we’ve made meaningful progress on our strategic priorities for 2018, including the achievement of Medicare coverage for FoundationOne CDx across all solid tumors for qualifying patients, new partnerships to expand our commercial presence in China and Japan, and new biopharma collaborations. In addition, we continued our focus on innovation by accelerating our path to potential regulatory approval of an expanded version of our liquid biopsy assay, FoundationACT, and by initiating the development of a gene expression profiling platform that could enhance biomarker discovery and clinical decision making particularly in the field of immunotherapy. Our many accomplishments reinforce our leadership position and competitive differentiation and, most importantly, help enable access to personalized cancer care."

Foundation Medicine reported total revenue of $52.8 million in the first quarter of 2018, compared to $26.3 million in the first quarter of 2017. Effective January 1, 2018, the company began recognizing revenue in accordance with FASB ASC Topic 606. The company adopted ASC Topic 606 utilizing the modified retrospective method. Additional details of the adoption of this new accounting standard and our revenue recognition policies will be included in the company’s first quarter 10-Q. A summary of revenue for the first quarter of 2018

Revenue from clinical testing in the first quarter of 2018 grew 62% year over year and was driven by increasing clinical volume. The company reported 21,861 clinical tests in the first quarter of 2018, a 57% increase from the same quarter last year. This number includes 17,685 FoundationOne tests, 2,005 FoundationOneHeme tests, 2,123 FoundationACT tests, and 48 FoundationFocus CDx BRCA tests.

Molecular Information Services revenue from biopharmaceutical companies was very strong and was driven by clinical study sample testing. The company reported 7,184 tests to biopharmaceutical customers in the first quarter of 2018 compared to 1,802 tests in the first quarter of 2017.

Total operating expenses for the first quarter of 2018 were $62.0 million compared with $55.0 million for the first quarter of 2017. Net loss was $37.4 million in the first quarter of 2018, or $1.02 loss per share.

Cash and cash equivalents at March 31, 2018 was approximately $60.3 million, including $30 million borrowed during the first quarter under the company’s Credit Facility Agreement with Roche Finance.

2018 Outlook

The company expects 2018 revenue will be in the range of $200 million to $220 million.
The company expects to deliver between 90,000 and 100,000 clinical tests in 2018.
The company expects operating expenses will be in the range of $250 million to $260 million in 2018.
Conference Call and Webcast Details
The company will conduct a conference call today, Wednesday, May 2nd at 4:30 p.m. Eastern Time to discuss its financial performance for the 2018 first quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-844-784-1732 from the United States or dial 1-412-902-6714 internationally. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.

City of Hope Becomes One of the First to Offer Tisagenlecleucel CAR T Cell Therapy for Adult Patients with the Most Common Type of Non-Hodgkin Lymphoma

On May 2, 2018 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it is one of the first treatment centers certified in the United States to administer tisagenlecleucel (commercial name Kymriah) chimeric antigen receptor (CAR) T cell therapy to adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (Press release, City of Hope, MAY 2, 2018, View Source [SID1234525988]). The U.S. Food and Drug Administration today approved tisagenlecleucel for its second indication, including the treatment of diffuse large B-cell lymphoma (DLBCL), the most common form of NHL, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

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!

City of Hope is the only institution in Southern California to currently offer both tisagenlecleucel, which was approved last year for pediatric patients with refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL), and axicabtagene ciloleucel (commercial name Yescarta), the second CAR T cell therapy approved by the FDA, solidifying City of Hope’s position as a leader in this newest form of cancer immunotherapy.

"City of Hope has an impressive legacy of innovation in the cancer space, and our role in making the science of CAR T cell therapy a reality is an example of our commitment to helping ensure that patients around the world have access to the most advanced therapies," said Stephen J. Forman, M.D., the Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation, and leader of the Hematologic Malignancies and Stem Cell Transplantation Institute. "Today’s supplemental approval for tisagenlecleucel is yet another important advance in CAR T therapy for non-Hodgkin lymphoma patients. In addition to City of Hope’s own clinical development programs, we are proud to be part of an exclusive group of institutions able to provide every commercial CAR T therapy to patients living with these aggressive and difficult-to-treat cancers, where other treatments have failed."

CAR T Expertise at City of Hope

City of Hope is a recognized leader in the advancement of CAR T cell therapies. City of Hope applies its proprietary CAR T cell technology in active preclinical and clinical programs across a range of hematologic cancers and solid tumors, and collaborates with other academic researchers and global biopharmaceutical companies to advance clinical research in areas of high unmet medical need and make their therapies available to patients.

City of Hope’s history with CAR T cell therapy dates back to the late 1990s. Since then, nearly 200 patients have been treated in CAR T trials at City of Hope; the institution was the first to administer CAR T cell therapy locally in the brain to glioblastoma patients through direct injection to the tumor site and/or through infusion in the ventricular system. City of Hope was also the first to offer CAR T trials targeting CD123 in acute myeloid leukemia.

City of Hope, which has one of the most comprehensive CAR T cell clinical research programs in the world, currently has 14 ongoing CAR T clinical trials and plans to open additional solid tumor trials in 2018 for patients with a variety of cancer types, including trials for patients with primary glioblastoma that expresses HER2 protein, patients with HER2-positive breast cancer with metastatic brain disease and patients with prostate cancer. City of Hope’s unique blend of multidisciplinary specialization – encompassing physicians, nurses and intensive care and transfusion medicine experts sharing stem cell transplant expertise – will also benefit CAR T patients, who require intensive medical care after treatment.

Patients interested in learning more about tisagenlecleucel treatment at City of Hope can call 833-310-CART (2278) or visit View Source

About non-Hodgkin Lymphoma

Lymphoma is the most common form of blood cancer, with Hodgkin lymphoma and non-Hodgkin lymphoma (NHL), which accounts for 4 percent of all cancer diagnoses in the United States, being the two main forms. Sixty percent of all NHL cases in the United States are aggressive NHL, with the most common subtype being DLBCL.

Approximately 74,680 people, both children and adults, are expected to be diagnosed with NHL in 2018, according to the American Cancer Society.

NHL includes multiple different subtypes, all originating in the lymphatic system, and occurs when either B or T cell lymphocytes, a type of white blood cell, become abnormal, causing such painful symptoms as enlarged lymph nodes, fever and fatigue. Refractory, or treatment-resistant, aggressive NHL grow quickly over time. Historically, patients have had about a 50 percent chance of surviving six months. Patients who are ineligible for or relapse after autologous stem cell transplant are eligible to receive tisagenlecleucel.

CEL-SCI CORPORATION ANNOUNCES UPCOMING INVESTOR CONFERENCE PRESENTATIONS

On May 2, 2018 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present at the following conferences (Press release, Cel-Sci, MAY 2, 2018, View Source [SID1234525987]):

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!

Mr. Kersten’s presentation will be available in the Investor Relations section of the Company’s website at www.cel-sci.com/investor_relations.html.

About The 2018 Disruptive Growth & Healthcare Conference

The 2018 Disruptive Growth & Healthcare Conference sponsored by RHK Capital and ReedSmith offers an opportunity to discover life science companies focusing on unmet medical needs with disruptive technologies and business models.

About The NYC Oncology Investor Conference 2018

The NYC Oncology Investor Conference 2018 hosted by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, Wilson Sonsini Law Firm, Torreya Partners, and Marcum is the leading conference for early-stage private and public cancer investing.