On November 4, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the third quarter ended September 30, 2019 (Press release, Mirati, NOV 4, 2019, View Source [SID1234550238]).

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Recent Corporate Updates:

Presented early clinical data from the Phase1/2 trial of MRTX849 on October 28, 2019 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). At the highest dose (600 mg BID), three of five (3/5) evaluable patients with non-small cell lung cancer (NSCLC) and one of two (1/2) evaluable patients with colorectal cancer (CRC) achieved a partial response (PR); the remaining patients had stable disease (SD). Across all dose levels, three of six (3/6) patients with NSCLC and one of four (1/4) patients with CRC achieved a PR. Two responding patients (1 NSCLC and 1 CRC) achieved confirmed PRs, both with continuing tumor shrinkage following their first scan. The other two patients with PRs (both NSCLC) have not had confirmatory scans. Clinical PK data demonstrated that the dose of 600 mg BID results in drug levels that meet or exceed those likely to lead to full inhibition of KRAS G12C signaling. Treatment duration ranged from 6.7- 38.6 weeks as of the data cut-off, October 11, 2019.

Published data demonstrating the efficacy of MRTX849 in preclinical studies on October 28, 2019 simultaneously with the Company’s oral presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), in Cancer Discovery, a journal of the American Association of Cancer Researchers.

Announced that the Company would have two presentations of interim Phase 2 data for sitravatinib in combination with nivolumab in urothelial carcinoma and oral cavity squamous cell carcinoma at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on November 9, 2019.

Announced on July 9, 2019 that the Company had entered into a clinical collaboration agreement with Novartis to evaluate the combination of MRTX849, Mirati’s investigational KRAS G12C inhibitor and TNO155, Novartis’ investigational SHP2 inhibitor, in patients with advanced solid tumors with KRAS G12C mutations.

"The recent data presented demonstrate that MRTX849 treatment can result in clinical responses at well tolerated doses. We believe that MRTX849 clinical combinations, including the combination of MRTX849 with TNO155 in our collaboration with Novartis, will significantly increase the eligible patient population," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati. "We continue to expand and accelerate our KRAS programs and expect to continue expanding our team, including the addition of commercial talent so that we are ready to deliver our novel cancer therapies to the patients most in need."

Financial Results for the Third Quarter 2019

Cash, cash equivalents, and short-term investments were $454.2 million at September 30, 2019, compared to $222.8 million at December 31, 2018. In January 2019, we completed a public offering of common stock that provided net cash proceeds of $107.9 million. In June 2019, we completed a public offering of common stock that provided net cash proceeds of $219.9 million.

License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and nine months ended September 30, 2019 were $1.0 million and $2.8 million, respectively, compared to none and $9.5 million for the three and nine months ended September 30, 2018, respectively. The 2019 revenues relate to revenues earned in connection with a manufacturing supply services agreement with BeiGene and the 2018 revenues relate to the license the Company granted to BeiGene under the Collaboration and License Agreement.

Research and development expenses for the third quarter of 2019 were $47.4 million, compared to $23.6 million for the same period in 2018. Research and development expenses for the nine months ended September 30, 2019 were $119.9 million, compared to $67.1 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with the development of sitravatinib and MRTX849, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The Company recognized research and development-related share-based compensation expense of $8.6 million during the third quarter of 2019, compared to $1.8 million for the same period in 2018, and $20.4 million during the nine months ended September 30, 2019, compared to $5.1 million for the same period in 2018.

General and administrative expenses for the third quarter of 2019 were $10.7 million, compared to $5.3 million for the same period in 2018. General and administrative expenses for the nine months ended September 30, 2019 were $30.3 million, compared to $15.3 million for the same period in 2018. The increase is due primarily to an increase in share-based compensation expense and, to a lesser extent, an increase in employee related expense, professional services expense and facilities and insurance expense. The Company recognized general and administrative-related share-based compensation expense of $6.5 million during the third quarter of 2019, compared to $2.2 million for the same period in 2018, and $18.4 million during the nine months ended September 30, 2019, compared to $6.5 million for the same period in 2018.

Net loss for the third quarter of 2019 was $54.3 million, or $1.38 per share basic and diluted, compared to net loss of $27.6 million, or $0.85 per share basic and diluted for the same period in 2018. Net loss for the nine months ended September 30, 2019 was $140.9 million, or $3.83 per share basic and diluted, compared to net loss of $70.1 million, or $2.31 per share basic and diluted for the same period in 2018.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small

cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified, KRAS G12C-positive advanced solid tumors.

On November 4, 2019 Laboratory for Advanced Medicine, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, reported the appointment of Kenneth Chahine, Ph.D., J.D., as Chief Executive Officer and board member (Press release, Laboratory for Advanced Medicine, NOV 4, 2019, View Source [SID1234550255]). He will succeed Founder Shu Li, Ph.D., who will continue to serve as Chairman of the company’s Board of Directors.

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"Dr. Chahine brings a unique combination of experience to the company. He has built, commercialized and scaled one of the largest consumer genomic business in the world, as well as operated in highly regulated therapeutic and diagnostic environments," said Shu Li, Ph.D., Chairman of Laboratory for Advanced Medicine. "Ken will drive the global commercialization of our liquid biopsy pipeline of products to detect liver, colon and breast cancer at early stages and unlock the full potential of the company’s AI-driven cfDNA methylation technology platform. We warmly welcome Ken to the team."

As Executive Vice President and GM of AncestryDNA, Ken created the vision and launched AncestryDNA in 2012 that has grown to become the leading direct-to-consumer genetic genealogy product in the market with over 15 million users. Most recently he led the launch of AncestryHealth, a physician-order LDT product that reports on genetic predisposition to conditions such as breast, ovarian and colon cancer, as well as cardiac and blood clotting disorders on an NGS platform. Prior to Ancestry, he was the Chief Executive Officer at Avigen, where he led the company to develop and commercialize innovative gene therapeutics. Dr. Chahine is on the faculty at the University of Utah’s College of Law and currently teaches a course in new venture development, intellectual property and licensing.

"I am excited to lead a mission-driven company that will bring about a global paradigm shift in early cancer detection and make a profound social impact. Laboratory for Advanced Medicine has positioned itself as one of the leaders in the field. I am honored to work with the dedicated and accomplished team of researchers and innovators at LAM to further advance the company’s technology and work to save lives through early cancer detection," said Dr. Chahine.

On November 4, 2019 FibroGen, Inc. (NASDAQ: FGEN), reported that financial results for the third quarter 2019 will be released after market on Monday, November 11, 2019 (Press release, FibroGen, NOV 4, 2019, View Source [SID1234550272]). An investor conference call will be held at 5:00 p.m. ET (2:00 p.m. PT) to discuss financial results and provide a business update.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 49125013

A replay of the webcast will be available after the call for a period of 30 days. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 4912 5013#.

On November 4, 2019 Sentinel oncology Limited reported an expansion of it’s collaboration with PhoreMost Limited to accelerate the development of SOL686, a novel allosteric Polo-like kinase 1 (Plk1) inhibitor (Press release, Sentinel Oncology, NOV 4, 2019, View Source [SID1234550397]). The programme adds to Sentinel Oncology’s NeuroOncology pipeline, has started formal preclinical studies and is positioned to enter clinical development as a glioma treatment by 2021.

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Mitotic PLKs are widely recognised as playing crucial roles in disease causing pathways, including K-Ras mutant cancers. Traditional approaches to drugging PLK enzymes have focused on targeting their active site; however this tactic has been hindered by toxicity-associated adverse events. Sentinel Oncology’s allosteric PLK1 inhibitor takes the novel approach of targeting the Polo-box domain (PBD) of the PLKs, thereby aiming to mitigate adverse events seen by active site inhibitors.

The programme has demonstrated a promising combination of specific drug-like properties, mode of action and target validation data obtained so far. The programme, which originated from the laboratory of Prof Ashok Venkitaraman at the University of Cambridge, has been optimised by both PhoreMost and Sentinel Oncology to the point where SOL686 was recently identified as a candidate drug for the treatment of glioma. Both PhoreMost and Sentinel Oncology received funding from Innovate UK for the drug discovery programme.

On November 4, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal first-quarter 2020, provided an update on recent business highlights and provided revised fiscal year and second-quarter 2020 financial guidance (Press release, Myriad Genetics, NOV 4, 2019, View Source [SID1234550239]).

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"We had a challenging start to fiscal year 2020 as hereditary cancer revenue accrual from small payers was impacted by the deletion of the historical hereditary cancer CPT codes. We had assumed this administrative change would have a minor impact to cash collections, but unfortunately, that has not proven to be the case. While the hereditary cancer business has returned to strong double-digit volume growth, the revenue accrual impact from these changes have led us to lower our financial outlook for the year," said Mark C. Capone, president and CEO, Myriad Genetics. "Despite this setback, we expect earnings to be significantly higher in the second half of the fiscal year and believe that a number of important upsides will materialize during the fiscal year generating momentum as we transition into fiscal year 2021."

Recent Business Highlights

Hereditary Cancer

In the fiscal first-quarter, Myriad made approximately an $11 million reserve adjustment for hereditary cancer revenue due to lower cash collections from small payers as a result of the deletion of the current procedural terminology (CPT) codes 81211 and 81213. As a result, the company has revised its revenue accrual rate, and is forecasting lower hereditary cancer rates for fiscal year 2020. Myriad will provide a detailed summary of the changes on its fiscal first-quarter 2020 earnings call.

Hereditary cancer volumes grew at a double-digit growth rate on a year-over-year basis for both the company’s oncology and women’s health business units.

GeneSight

Announced coverage decision from UnitedHealthcare, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Signed master service agreement with a large pharmacy benefit manager in the United States to offer GeneSight to its commercial payer and self-funded employer customers. A Fortune 50 company has already opted into the master service agreement.

Published the precision medicine analysis of the GUIDED study in the Journal of Clinical Psychiatry. The study evaluated 787 patients at baseline who were on medications with known gene drug interactions. The analysis showed that patients who had their treatment guided by GeneSight saw a 70 percent improvement in remission, 42 percent improvement in response, and a 23 percent improvement in symptoms, all of which were statistically significant.

Prenatal

Received acceptance for publication for new data in Prenatal Diagnosis demonstrating that Prequel is the only non-invasive prenatal screening (NIPS) test that outperforms traditional measures of aneuploidy detection across all classes of obesity. Other NIPS testing methodologies can have failure rates up to 24 percent in obese patients leading the American College of Gynecology to recommend against using NIPS in patients with significant obesity.

Prolaris

blished a clinical outcomes study in Personalized Medicine that demonstrated the Prolaris test can identify men with low-risk prostate cancer who can safely select active surveillance (AS) and defer the need for costly treatments such as radiation therapy or surgery. In the study of 664 men with low risk prostate cancer, 82.4 percent selected AS for their initial treatment and only 0.4 percent experienced disease progression. Additionally, the AS decision was durable with 91.2 percent of men remaining on AS at year one and 65.2 percent at year four.

Companion Diagnostics

Filed a supplementary Premarket Approval Application with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in metastatic, castrate-resistant, prostate cancer patients with germline BRCA mutations.

Received the first FDA approval for myChoice CDx as a companion diagnostic to identify women with ovarian cancer who are candidates for Zejula monotherapy in the late-line setting.

Submitted our myChoice CDx test for approval by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in ovarian cancer.

Fiscal Year 2020 and Fiscal Second-Quarter 2020 Financial Guidance

Below is a table summarizing Myriad’s fiscal year 2020 and fiscal second-quarter 2020 financial guidance:

Revenue

Myriad’s fiscal year 2020 and second-quarter 2020 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 first-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Monday, November 4, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-945-0427. International callers may dial 1-212-231-2918. All callers will be asked to reference reservation number 21931991. 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.