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Personalis, Inc. Expands Oncology Portfolio With the Launch of Cancer Whole Genome Sequencing Services

On November 12, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of Personalis’ Cancer Whole Genome Sequencing which further extends Personalis’ portfolio of comprehensive cancer genomics services designed to maximize biological insights from tumor samples (Press release, Personalis, NOV 12, 2019, View Source [SID1234551009]).

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"This new offering continues our push to provide our customers genomics solutions that enable deeper insights into patient responses to oncology therapies," said John West, CEO of Personalis. "We are uniquely poised to provide a leading cancer whole genome sequencing solution which combines Personalis’ deep technology and experience in analyzing cancer samples for biopharma oncology clinical trials and the large-scale laboratory and data systems developed for the VA MVP program, one of the largest whole genome sequencing programs in the world."

Earlier this year, Personalis was awarded a new task order under its contract with the U.S. Department of Veterans Affairs (VA) for the VA Million Veteran Program (VA MVP). This order brought the cumulative scale of orders received to date from the VA MVP to over 110,000 human genomes. Since 2013, Personalis has sequenced over 40,000 MVP samples. Personalis anticipates it will sequence the additional samples over the coming years as they are received from the VA.

"As our understanding of the complexity of underlying mechanisms of cancer grows, it is becoming increasingly important to evaluate genome-wide structural variants, and other forms of non-coding genetic variation," commented Dr. Richard Chen, CSO of Personalis. "This new service advances our position at the leading edge of cancer translational research with biopharma customers."

Exelixis to Present at the Stifel 2019 Healthcare Conference on November 19, 2019

On November 12, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the Stifel 2019 Healthcare Conference being held next week in New York (Press release, Exelixis, NOV 12, 2019, View Source [SID1234551008]). Exelixis’ presentation has been scheduled for Tuesday, November 19, 2019 at 9:10 AM EST / 6:10 AM PST.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

Baystate Health and Life Image Announce Strategic Partnership to Develop AI Innovations to Improve Treatment Decisions and Match Cancer Patients to Clinical Trials

On November 12, 2019 Baystate Health, the premier integrated health system serving more than 800,000 patients in western New England, reported a strategic partnership with Life Image, the largest medical evidence network providing access to points of care and curated clinical and imaging data, to develop novel artificial intelligence tools that would help advance technical innovations in radiology, neurology and oncology (Press release, Baystate Health, NOV 12, 2019, View Source [SID1234551007]).

Specifically, TechSpring, the innovation arm for Baystate, will work closely with Life Image to evaluate a number of AI solutions including those that promise to improve speed and accuracy in diagnosing blood clots in stroke patients; improve clinical pathways for physicians treating or diagnosing a patient by finding and comparing clinical criteria against a group of de-identified patients with similar clinical characteristics; and identify potential patient matches to oncology clinical trials in order to advance cancer research as well as give western New England residents better access to potentially life-saving treatments.

Baystate and Life Image began working together 10 years ago when the health system became one of the company’s first customers. Life Image created the image exchange category when it developed solutions more than a decade ago to help solve the many technical and structural barriers that prevented the seamless exchange of medical images.

With its beginnings in image exchange, Life Image is now a global medical evidence network that offers ‘living’ datasets of novel imaging data that’s linkable to other clinical information and provides network access to points-of-care to enable improved care delivery, novel research and innovation.

Baystate has been a healthcare innovator since 1873 when it first established the modern American hospital in Springfield, which was one of only 178 acute care hospitals in the country. Baystate has played an important role in the evolution of the healthcare industry by advancing leading-edge methods such as fast-track cardiac, chronic care, homeopathic medicine and educational innovation for physicians and nurses.

"Baystate Health and TechSpring are excited to partner with Life Image on the next generation of healthcare technology with AI initiatives that have targeted use cases with high clinical utility and value," said Richard Hicks, MD, Department Chair of Radiology at Baystate. "For example, by understanding how similar patients may have been diagnosed or treated can help improve accuracy and, ultimately, patient outcomes."

Baystate launched TechSpring five years ago to accelerate innovation in healthcare informatics and technology in order to solve the challenges of healthcare. TechSpring provides technology companies access to a real, live health system using a proven process and platform to test and validate digital health solutions.

"TechSpring has tackled a variety of challenges for Baystate, from transitions in care to operational efficiencies. This is a big, bold next step into the world of AI," said Joel Vengco, Vice President, Chief Information Officer and TechSpring Founder. "Baystate is a living lab to pursue those big ideas, learn quickly and eventually share with the wider market."

"Life Image enables creative collaborations outside of healthcare’s traditional silos through use of its leading technical capabilities and unmatched evidence-based network," said Matthew A. Michela, President and CEO of Life Image. "This partnership with Baystate and TechSpring will facilitate new breakthrough technologies that work in the real healthcare world, specifically in the practice setting where patients and clinicians interact."

Accenture analyzed key clinical health AI applications and found that they can potentially create $150 billion in annual savings in the United States by 2026. A McKinsey report found that a potential for healthcare AI to deliver between $350 billion and $410 billion in annual value by 2025.

Syros Reports Third Quarter 2019 Financial Results and Highlights Key Accomplishments and Upcoming Milestones

On November 12, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended September 30, 2019, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, NOV 12, 2019, View Source [SID1234551006]).

"At Syros, we are focused where we believe we have the greatest potential to make a profound difference for patients by developing small-molecule medicines to control the expression of genes," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "This quarter, we made important strides on that front. We reported strong clinical data from our Phase 2 trial of SY-1425 in RARA-positive newly diagnosed unfit AML patients, showing that our discovery of this novel patient subset is translating into clinical benefit. Building on our leadership in selective CDK7 inhibition, we presented new preclinical data on SY-5609 in models of difficult-to-treat solid tumors, highlighting its best-in-class potential as an oral CDK7 inhibitor. These data inform our clinical development plans for both programs and provide us a clear path to make meaningful progress across our pipeline next year. We look forward to reporting potential proof-of-concept data in 2020 for SY-1425 in relapsed or refractory RARA-positive AML patients and to initiating a Phase 1 study of SY-5609 in select solid tumors in the first quarter of 2020."

Upcoming Milestones:

SY-1425

Syros plans to complete enrollment in the newly diagnosed unfit AML cohorts of the ongoing Phase 2 trial in the fourth quarter of this year.
Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in RARA-positive patients with relapsed or refractory AML in 2020.
SY-5609

Syros plans to complete investigational new drug application-enabling studies by year-end and initiate a Phase 1 trial of SY-5609 in the first quarter of 2020 in patients with select solid tumors, including breast, lung and ovarian cancers, and solid tumors of any histology harboring Rb pathway alterations.
Discovery-Stage Pipeline

Syros plans to present on its identification and validation of a novel Fetal Hemoglobin (HbF) repressor in an oral presentation at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. This finding is part of Syros’ broader drug discovery effort to develop small molecules to increase the expression of fetal hemoglobin with the aim of treating sickle cell disease. In addition to the oral presentation, the research has been selected for includsion in the ASH (Free ASH Whitepaper) press program.
Together with its collaborators at the Whitehead Institute for Biomedical Research, Syros plans to present on the identification of core drivers of metastasis in triple-negative breast cancer (TNBC) in a poster presentation at the 2019 San Antonio Breast Cancer Symposium.
Recent Pipeline Highlights:

In October 2019, Syros presented new clinical data from its Phase 2 trial evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard intensive chemotherapy. The data, presented at the European Society of Haematology International Conference on Molecular and Translational Advances in AML, showed:
62% complete response (CR) and complete response with incomplete blood count recovery (CRi) rate in RARA-positive patients.
54% CR rate in RARA-positive patients, consisting of seven CRs, including three molecular CRs and three cytogenetic CRs.
Most initial responses in RARA-positive patients were seen at the end of the first 28-day treatment cycle.
Duration of responses in RARA-positive patients was up to 344 days, with three of the eight responding patients having a CR lasting more than seven months at the time of the Aug. 22 data cutoff.
82% of RARA-positive patients achieved or maintained transfusion independence.
By comparison, the CR/CRi rate in RARA-negative patients was 27%, supporting the use of the RARA biomarker for patient selection.
The combination was generally well-tolerated, with no increased toxicities beyond what has been seen with either agent alone.
In October 2019, Syros presented new preclinical data on SY-5609 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). The data demonstrated robust dose-dependent anti-tumor activity in preclinical models of difficult-to-treat solid tumors, including induction of complete regressions as a single agent at doses below the maximum tolerated dose. Rb pathway alterations were associated with deeper, more sustained responses.
In October 2019, Syros provided an update on its selective CDK7 inhibitor portfolio, prioritizing the development of SY-5609 and discontinuing development of SY-1365.
Third Quarter 2019 Financial Results:

Syros had cash, cash equivalents and marketable securities of $108.1 million as of September 30, 2019, as compared with $99.7 million in December 31, 2018. This increase in cash reflects aggregate net proceeds of approximately $65.0 million from Syros’ two concurrent underwritten public offerings, which closed in April 2019.

For the third quarter of 2019, Syros reported a net loss of $19.8 million, or $0.47 per share, compared to a net loss of $15.7 million, or $0.47 per share, for the same period in 2018.

Revenues were $0.6 million for the third quarter of 2019, as compared to $0.4 million for the third quarter of 2018. Revenues in both the third quarter of 2019 and the third quarter of 2018 were earned under Syros’ collaboration with Incyte Corporation.
Research and development (R&D) expenses were $15.9 million for the third quarter of 2019, as compared to $12.9 million for the same period in 2018. This increase was primarily attributable to continued advancement of the Company’s existing clinical trials and advancement of its preclinical programs, including completing SY-5609 IND-enabling studies.
General and administrative (G&A) expenses were $5.0 million for the third quarter of 2019, as compared to $3.9 million for the same period in 2018. This increase was primarily attributable to an increase in employee-related expenses.
Updated Financial Guidance:
Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements to the end of the second quarter of 2021.

Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these third quarter 2019 financial results and provide a corporate update.

To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international), and refer to conference ID 1994858. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.

UroGen Pharma Reports Third Quarter 2019 Financial Results and Recent Corporate Developments

On November 12, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported financial results for the third quarter ended September 30, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, NOV 12, 2019, View Source [SID1234551005]).

"On behalf of the UroGen team, we are very pleased to announce that we have completed the New Drug Application (NDA) submission for UGN-101 to the FDA. This is a very important milestone for UroGen and for patients with low-grade UTUC as UGN-101 has the potential to bring the first primary chemoablation drug to these patients. I am proud of the UroGen team and investigators who have helped to make this key milestone a reality," said Liz Barrett, President and Chief Executive Officer of UroGen. "Beyond UGN-101, we have taken important steps to build a company that can deliver long-term sustainable growth through our focus on high unmet need areas utilizing both local delivery and novel medicines. We’ve demonstrated that relentless commitment with our recently announced positive complete response data for investigational agent UGN-102 in patients with intermediate risk LG NMIBC, and our exclusive collaboration with Agenus to advance therapies for high-grade urinary tract cancers. We look forward to a strong future for UroGen."

Recent Highlights and Upcoming Milestones

UGN-101 (mitomycin gel) for instillation for patients with low-grade upper tract urothelial cancer (LG UTUC):
The Company completed its NDA submission to the FDA, and the FDA has a 60-day filing review period to determine whether the NDA submission is complete. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of LG UTUC. UGN-101 is eligible for Priority Review and the Company is planning for anticipated approval and launch in 1H 2020. UGN-101 plans for launch readiness are on track for January 2020.
The NDA submission is supported by positive data from the pivotal Phase 3 OLYMPUS clinical trial.
UroGen also initiated a retreatment protocol as an extension to OLYMPUS to evaluate the efficacy and safety of retreatment with UGN-101 in patients from the trial who initially achieved a CR and were subsequently found to have a documented recurrence of LG UTUC during follow-up.
UGN-102 (mitomycin gel) in development for intravesical instillation for patients with intermediate risk low-grade non-muscle invasive bladder cancer (LG NMIBC):
UroGen recently presented interim results from the single-arm, open-label Phase 2b OPTIMA II trial of investigational UGN-102 for patients with intermediate risk LG NMIBC. LG NMIBC is defined as those with one or two of the following criteria: multifocal disease, large tumors and rapid rates of recurrence.
In an interim analysis, 63% (20/32) of patients from the Phase 2b OPTIMA II trial achieved a CR. Patients will continue to be followed with 12-month durability to be reported at a later date.
The most common treatment emergent adverse events (TEAEs) included dysuria, pollakiuria, fatigue, hematuria and urinary tract infection. The majority were characterized as mild or moderate in severity and transient.
The trial completed enrollment of 63 patients ahead of schedule at clinical sites across the U.S. and Israel. The Company intends to initiate a pivotal Phase 3 trial in 2020 following a planned discussion with the FDA in 1Q 2020.
This is a patient population whereby the current standard of care, transurethral resection of bladder tumor, or TURBT, is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to "manage" bladder cancer recurrences.
There are no drugs currently approved by the FDA as first-line treatment for intermediate risk LG NMIBC. UGN-102 has the potential to provide a non-surgical alternative for the treatment of chronic relapse for approximately 80,000 patients characterized as intermediate risk.
Pipeline Advancement:
UGN-201 (TLR 7/8 agonist) for patients with high-grade NMIBC:
UroGen is exploring the utility of UGN-201 in the context of novel combinatorial immunotherapy for NMIBC. Nonclinical data suggests an efficacy signal when UGN-201 is administered locally with anti-CTLA4 antibody in a murine model of high-grade bladder cancer. The Company plans to optimize combinations and advance into human studies.
Exclusive Worldwide License Agreement with Agenus Inc. to Advance Treatment of High-Grade Urinary Cancers
UroGen entered into an exclusive worldwide license agreement with Agenus to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) in combination with UGN-201 for the treatment of urinary tract cancers via intravesical delivery. Zalifrelimab (AGEN1884, anti-CTLA-4 antibody) is currently being evaluated by Agenus as a monotherapy in PD-1 refractory patients.
The initial indication for development will be high-grade NMIBC.
UroGen will be responsible for all development and commercialization activities.
Third Quarter 2019 Financial Results; 2019 Guidance

As of September 30, 2019, cash, cash equivalents and marketable securities totaled $221.7 million.
Research and development expenses for the three months ended September 30, 2019 were $9.5 million, including non-cash share-based compensation expense of $2.1 million. Research and development expenses for the nine months ended September 30, 2019 were $29.2 million, including non-cash share-based compensation expense of $6.4 million.
General and administrative expenses for the three months ended September 30, 2019 were $14.0 million, including non-cash share-based compensation expense of $5.2 million. General and administrative expenses for the nine months ended September 30, 2019 were $40.5 million, including non-cash share-based compensation expense of $15.5 million.
The Company reported a net loss of $22.3 million, or basic and diluted net loss per ordinary share of $1.06, for the three months ended September 30, 2019. The Company reported a net loss of $66.2 million, or basic and diluted net loss per ordinary share of $3.25, for the nine months ended September 30, 2019.
Including the recently announced Agenus deal, the Company is still on track to end the year with a net loss for the year in the range of $100 to $110 million, which is expected to include non-cash stock-based compensation expense in the range of $28 to $30 million, subject to market conditions.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 am Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 49159339. An archive of the webcast will be available for two weeks on the Company’s website.