On August 21, 2018 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal fourth-quarter and full-year 2018, provided an update on recent business highlights and issued its fiscal year and first-quarter 2019 financial guidance (Press release, Myriad Genetics, AUG 21, 2018, View Source [SID1234529019]).

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"Fiscal year 2018 was an excellent year for Myriad as record-setting growth in new products with increasing reimbursement added to a solid hereditary cancer business and a re-engineered cost structure," said Mark C. Capone, president and CEO, Myriad Genetics. "Based upon our operational momentum and the recent completion of the Counsyl acquisition, we are confident in our strategy to transform Myriad into the global leader in personalized medicine."

Financial Highlights

The following table summarizes the financial results for the fiscal fourth-quarter and fiscal full-year 2018

Revisions of Previously-Issued Financial Statements: During the financial close for fiscal year 2018, the Company determined that it had not fully reserved for its sales allowance for the financial periods from fiscal year 2015 through fiscal year 2018. These errors which represented less than one percent of total revenue during that time frame were determined to be. The financial information for prior periods has been restated to reflect these adjustments.

Business Highlights

Hereditary Cancer

Achieved sixth consecutive quarter of year-over-year hereditary cancer testing volume growth.

Announced the second major clinical validation study for riskScore at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The study evaluated 518 women and found that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=2.6×10-12 and p=2.5×10-12, respectively). Moreover, riskScore was statistically significantly superior to Tyrer-Cuzick alone for both 5-year and lifetime risk of breast cancer (1.9×10-8 and p=2.4×10-8, respectively), underscoring the independent contribution of the combined test score.

Based upon recent changes to the National Comprehensive Cancer Network professional treatment guidelines for prostate, pancreatic and colon cancer, we estimate 121,000 additional cancer patients now qualify for hereditary cancer testing in the United States every year.

GeneSight

Fiscal fourth-quarter revenue increased 33 percent year-over-year to $33.9 million with record volumes in the quarter.

A record 15,000 physicians, including almost 3,000 new ordering doctors, ordered a GeneSight test in the fiscal fourth-quarter.

Presented the results from the GeneSight GUIDED randomized controlled trial at the American Psychiatric Association annual meeting. The landmark study showed that patients receiving GeneSight had significantly better outcomes with a 50 percent increase in remission rates and a 30 percent increase in response rates relative to standard-of-care therapy.

Announced the results of the IMPACT study at the American Society of Clinical Psychopharmacology annual meeting. In the study, patients treated by primary care physicians had 33 percent greater symptom improvement, 34 percent increased response and 57 percent greater remission than those treated by psychiatrists.

CareFirst, the 15th largest commercial payer in the United States, announced a favorable coverage policy for GeneSight taking effect August 1, 2018 which included all physician specialties.

Announced a new coverage decision for GeneSight with a major U.S. company with 30,000 employees.

In late-stage negotiations with Kroger Prescription Plans on a potential favorable coverage decision for GeneSight.

Vectra DA

Fiscal fourth-quarter revenue increased 47 percent year-over-year to $15.1 million.

Announced a favorable coverage decision for Vectra DA from Kroger Prescription Plans, the pharmacy benefits manager for Kroger and other employers. Kroger is the fourth largest employer in the United States.

Prolaris

Fiscal fourth-quarter revenue increased 133 percent year-over-year to $7.0 million with record volumes in the quarter.

Received positive medical policy recommendations on Prolaris from eight commercial insurers, including a top-10 commercial insurer, and seven others, totaling over 20 million covered lives or 12 percent of total commercial lives in the United States. Prolaris is now covered for approximately 55 percent of prostate cancer patients in the United States.

EndoPredict

Fiscal fourth-quarter revenue increased 40 percent year-over-year to $2.8 million.

Received positive recommendation from the National Institute for Health and Care Excellence (NICE) in the United Kingdom to cover the EndoPredict test.

myPath Melanoma

Received positive medical policy recommendations on myPath Melanoma from eight commercial insurers.

Companion Diagnostics

Metastatic breast cancer patients tested by Myriad increased 13 percent sequentially based upon the recent launch of BRACAnalysis CDx as a companion diagnostic for Lynparza.

Received pre-market approval from the Japanese Ministry of Health, Labor, and Welfare for our BRACAnalysis CDx test for HER2- metastatic breast cancer.

Announced positive results from Phase III, SOLO-1 study which evaluated patients with advanced ovarian cancer treated in the first-line setting who tested positive with Myriad’s BRACAnalysis CDx test. Myriad intends to submit a supplementary pre-market approval (sPMA) to the U.S. Food and Drug Administration (FDA) for this indication.

Announced that the FDA has accepted Myriad’s sPMA application for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s PARP inhibitor, talazoparib, in HER2- metastatic breast cancer. The New Drug Application for talazoparib has been granted priority review by the U.S. FDA and has a Prescription Drug User Fee Act goal date of December 2018.

Closing of Counsyl Acquisition

Myriad signed a definitive agreement to acquire Counsyl, Inc., a global leader in reproductive genetic testing, which closed on July 31, 2018. The acquisition of Counsyl provides Myriad with two new products, ForeSightTM and PreludeTM, in the expanded carrier screening and non-invasive prenatal screening markets respectively. Myriad

estimates that these markets will grow to approximately 3 million tests performed annually in the United States and $1.5 billion of revenue over the next five years.

Fiscal Year 2019 and Fiscal First-Quarter 2019 Financial Guidance

Myriad’s fiscal year 2019 and fiscal first-quarter 2019 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, August 21, 2018, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-616-4021. International callers may dial 1-303-223-2682. All callers will be asked to reference reservation number 21892392. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On August 21, 2018 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use in urothelial carcinoma (Press release, Agilent, AUG 21, 2018, View Source [SID1234529017]).

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The assay is now approved to identify patients with urothelial carcinoma who may benefit from KEYTRUDA, an anti-PD-1 therapy manufactured by Merck (known as MSD outside the United States and Canada), as a first-line treatment option. KEYTRUDA is approved for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to identify patients with urothelial carcinoma for treatment with KEYTRUDA. This follows previous FDA approvals for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer.

"Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy. Through these efforts, we maintain our commitment to bringing companion diagnostics to the market in support of groundbreaking immuno-oncology therapeutics."

Urothelial carcinoma is the fifth most common cancer in the United States, with an estimated incidence of 81,000 new cases in 2018 alone.1 For patients with advanced/metastatic urothelial carcinoma, cancer-related mortality has not improved in the past 30 years and the five-year survival rate is approximately 15%.2 Additionally, age- and disease-associated comorbidities affect patient eligibility for standard cisplatin-containing chemotherapy.3-5 For patients ineligible for cisplatin-containing chemotherapy, there is a significant unmet need for new, effective treatments.3,4

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, and their therapeutic value is being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck. PD-L1 IHC 22C3 pharmDx also helps physicians identify NSCLC, cervical cancer, and gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA. PD-L1 expression in urothelial carcinoma, cervical cancer, and gastric or GEJ adenocarcinoma tissues is interpreted using Combined Positive Score (CPS). PD-L1 expression in NSCLC tissues is interpreted using Tumor Proportion Score (TPS).

References: 1. Noone AM, Howlader N, Krapcho M, Miller D, Brest A, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA, eds. SEER Cancer Statistics Review, 1975-2015. National Cancer Institute. View Source November 2017 SEER data submission. Published April 2018. Accessed August 16, 2018. 2. Gupta S, Gill D, Poole A, Agarwal N. Systemic immunotherapy for urothelial cancer: current trends and future directions. Cancers. 2017;9(15):1-14. 3. Bellmunt J, Mottet N, De Santis M. Urothelial carcinoma management in elderly or unfit patients. EJC Suppl. 2016;14(1):1-20. 4. Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): A multicentre, single-arm, phase 2 study. Lancet. 2017;18(11):1483-1492. 5. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer "unfit" for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432-2438.

On August 21, 2018 Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that company management will present at the following upcoming investor and industry conferences (Press release, Genprex, AUG 21, 2018, View Source [SID1234529016]):

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Event: H.C. Wainwright 20th Annual Global Investment Conference
Date: September 6, 2018
Time: 5:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO
Event: Newsmakers in the Biotech Industry
Date: September 7, 2018
Time: 1:30 PM EDT
Location: New York, NY
Presenter: Dr. Julien Pham, President and COO

On August 21, 2018 Sensei Biotherapeutics, Inc., a privately-held biopharmaceutical company developing immuno-oncology therapies that teach the immune system to recognize and attack cancer, reported the appointment of Ildiko Csiki, M.D., Ph.D., as Chief Medical Officer (Press release, Sensei Biotherapeutics, AUG 21, 2018, View Source [SID1234529015]). Dr. Csiki brings nearly two decades of leadership experience in oncology drug development and research, most recently serving as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals.

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"It is with great excitement that we welcome such an accomplished oncologist and clinical leader to Sensei. Ildiko brings an outstanding intellect, expertise and passion for patients to our team," said John Celebi, CEO of Sensei Biotherapeutics. "She is joining Sensei at a time when we are taking bold steps in discovering and developing the next generation of cancer immunotherapies, and we look forward to her contributions to building our oncology drug development capabilities and developing the clinical strategies for SNS-301 and the other programs in our pipeline."

Dr. Csiki joins Sensei at a pivotal time with promising clinical data from the Phase I trial of its lead drug candidate SNS-301 expected in the fall of 2018, and the continued development of its proprietary SPIRIT drug development platform that is generating a pipeline of innovative immuno-oncology therapies.

"I am excited to join Sensei and have the opportunity to play a leadership role in advancing innovative immuno-oncology drug candidates and bring new medicines to cancer patients," said Ildiko Csiki, CMO of Sensei Biotherapeutics "Our SPIRIT platform offers an innovative mechanism for detecting and eliminating cancer. I am eager to move forward with the clinical program for Sensei’s lead drug candidate, SNS-301, as well as creating the clinical strategy for the company’s pipeline of immuno-oncology therapies with the potential to have a profound impact for cancer patients."

In her most recent role, Dr. Csiki served as Vice of President of Immuno-Oncology Clinical Development at Inovio Pharmaceuticals where she led the advancement of Inovio’s DNA-based cancer immunotherapies based on T cell immunotherapeutic vaccines, including responsibility for overseeing clinical programs, clinical strategy, medical monitoring and regulatory submissions. Previously, Dr. Csiki was a Senior Director of Oncology Clinical Development at Merck, as a clinical development lead for pembrolizumab (Keytruda), and she was Director of Clinical Development at GSK focused on a lymphoma and other oncology programs. Before that, Dr. Csiki was an Assistant Professor in the Perelman Cancer Center at the University of Pennsylvania where she had an active clinical practice and a translational science laboratory focused on thoracic malignancies. She holds an M.D. and Ph.D. from Vanderbilt University School of Medicine. Her postdoctoral training included an internship in Internal Medicine and residency in radiation oncology at Vanderbilt and subsequently, a Holman Pathway Research Fellowship.

On August 21, 2018 Ichor Medical Systems, Inc. (Ichor) reported that its investigational TriGrid Delivery System (TriGrid) is being utilized in a Phase 1b/2 clinical trial to administer GX-188E, an investigational therapeutic HPV DNA vaccine developed by Genexine, Inc (Press release, Ichor Medical Systems, AUG 21, 2018, View Source [SID1234529014])., in patients with human papilloma virus (HPV)-induced advanced non-resectable cervical cancer, in combination with an anti-PD-1 therapy (NCT03444376).

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Cervical cancer is the fourth most common cancer affecting women worldwide and is almost always caused by infection with HPV. Preventative vaccines for cervical cancer are ineffective in women who are already infected with HPV, and despite advances in screening and HPV vaccination, a significant number of women develop advanced disease. Although chemotherapy is the standard first-line treatment for advanced cervical cancer, the prognosis remains poor and effective second line options are still needed.

Ichor’s patented TriGrid Delivery System uses electroporation to open pathways into cells to facilitate entry of a DNA vaccine into its intracellular site of action. The TriGrid has been utilized in >25 clinical studies, including randomized comparative studies demonstrating that administration of DNA vaccines with the TriGrid device significantly enhanced immune responses to the vaccines compared to conventional injection. A Phase 1 study using the TriGrid to deliver GX-188E in patients with high grade cervical intraepithelial neoplasia (CIN), a precancerous stage of cervical cancer, showed promising results with GX-188E demonstrating the ability to induce a tumor-specific immune response with evidence of lesion clearance (Nat Commun. 2014 Oct 30; 5: 5317).

Immuno-oncology is a rapidly evolving field of medicine designed to improve the ability of a patient’s immune system to detect and destroy tumors. The study has been initiated in Korea with plans to enroll up to 46 patients and was recently announced by Genexine.

Robert Bernard, Ichor Founder and CEO, stated, "Ichor’s TriGrid Delivery System is a platform technology used by an increasing number of Ichor partners for clinical delivery of their DNA vaccines where T-cell generation is a critical aspect of the prescribed immunotherapy. We are pleased through our Genexine partnership to expand TriGrid’s use into additional areas of immuno-oncology around the world."