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GenomOncology’s Precision Oncology Platform to be implemented at Nationally Recognized Academic Medical Center

On November 7, 2019 GenomOncology, LLC (GO) reported that it was selected by the Duke Cancer Institute to utilize GO’s Precision Oncology Platform to provide real-time therapeutic, prognostic, and clinical trial recommendations to molecular tumor board organizers and participants at Duke Cancer Institute (Press release, GenomOncology, NOV 7, 2019, View Source [SID1234550691]). Duke will leverage GenomOncology’s GO Connect product to automatically load patient, molecular, and institutional trial data into GO’s Knowledge Management System (KMS) for use by Duke in GO’s Molecular Tumor Board Application. This will include incorporating information from Duke’s clinical data warehouse, multiple Next Gen Sequencing vendors, and OnCore.

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The GO KMS enables precision health approaches by allowing physicians and researchers to aggregate and analyze biomarker-based data within a ‘genomics-aware’ framework that includes a diverse set of annotations including genes, pathways, drugs, alterations, transcripts, and diseases. GO’s KMS clinical trial database contains over 4,100 clinical trials curated by the My Cancer Genome team for comprehensive clinical reporting.

Autolus Therapeutics Reports Third Quarter 2019 Financial Results and Operational Progress

On November 7, 2019 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2019 (Press release, Autolus, NOV 7, 2019, View Source [SID1234550680]).

"We are excited about the opportunity to share data updates at ASH (Free ASH Whitepaper) on AUTO1 in ALL in three oral presentations, as well as an oral presentation on AUTO3 in DLBCL. We are also looking forward to presenting data on our other hematological clinical programs at ASH (Free ASH Whitepaper), and non-clinical data on our lead solid tumor program AUTO6NG at SITC (Free SITC Whitepaper)," stated Dr. Christian Itin, chairman and chief executive officer of Autolus. "This quarter we have made significant operational progress, delivering cell products from our new manufacturing operations at the Cell and Gene Therapy Catapult and further strengthening our management team. Supported by a strong balance sheet, our key focus is on moving AUTO1 into our first pivotal clinical program in adult patients with ALL."

Pipeline Updates:

On November 5, the United States Food and Drug Administration granted orphan drug designation for AUTO1 for the treatment of acute lymphoblastic leukemia (ALL).

SITC Meeting Presentation

Solid tumors (AUTO6NG) – AUTO6NG: Next generation GD2-targeting CAR T-cell therapy with improved persistence and insensitivity to TGFb and checkpoint inhibition for relapsed/refractory neuroblastoma (Saturday November 9, poster presentation)

ASH Meeting Presentations

Adult ALL (AUTO1) – AUTO1, a novel fast off CD19 CAR delivers durable remissions and prolonged CAR T cell persistence with low CRS or neurotoxicity in adult ALL (Saturday December 7, oral presentation)

Pediatric ALL (AUTO1) – Therapy of pediatric B-ALL with a lower affinity CD19 CAR leads to enhanced expansion and prolonged CAR T cell persistence in patients with low bone marrow tumor burden, and is associated with a favorable toxicity profile (Saturday December 7, oral presentation)

Integration Site Analysis (AUTO1) – Clonal dynamics of early responder and long-term persisting CAR-T cells in humans (Saturday December 7, oral presentation)

DLBCL (AUTO3) – Phase 1/2 study of AUTO3 the first bicistronic chimeric antigen receptor (CAR) targeting CD19 and CD22 followed by an anti-PD1 in patients with relapsed/refractory (r/r) Diffuse Large B Cell Lymphoma (DLBCL): Results of Cohort 1 and 2 of the ALEXANDER study (Saturday December 7, oral presentation)

Multiple Myeloma (AUTO2) – Phase 1 First-in-Human study of AUTO2, the first chimeric antigen receptor (CAR) T cell targeting APRIL for patients with relapsed/refractory Multiple Myeloma (RRMM) (Sunday December 8, poster presentation)

Pediatric ALL (AUTO3) – Phase 1 Study of AUTO3, a Bicistronic Chimeric Antigen Receptor (CAR) T-cell Therapy Targeting of CD19 and CD22, in Pediatric Patients with Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL): AMELIA Study (Sunday December 8, poster presentation)
Operational and Corporate Highlights:

Manufacturing update

The Cell and Gene Therapy Catapult site is fully operational and is delivering clinical products for patients in both Europe and the US

Significant change in shareholder base

In September, PPF Group announced that they had acquired, mainly from Woodford Investment Management, an approximate 19% holding of Autolus. Control of all the remaining shares of Autolus held by Woodford Investment Management are in the process of being transferred to Schroder UK Public Private Trust plc.

Nature Medicine publication of AUTO1 CARPALL study in pediatric ALL

In September, Autolus announced that the journal Nature Medicine has published both pre-clinical results and clinical data from the ongoing Phase 1 CARPALL trial of AUTO1, demonstrating the potential of the company’s novel CAR T therapy targeting CD19 in development for the treatment of pediatric acute lymphoblastic leukemia (ALL).

Executive Leadership Team Changes

David Brochu has been named Senior Vice President, Head of Product Delivery to lead the transition of the company’s manufacturing organization to deliver products for late-stage clinical studies and commercial sale. In addition, Vishal Mehta has been named Vice President, Head of Clinical Operations.
Key Upcoming Clinical Milestones:

Initiation of the pivotal program of AUTO1 in adult ALL on track – dosing of first patients in the first half of 2020

Go/no go decision on Phase 2 initiation of AUTO3 in DLBCL expected in mid-2020

Interim Phase 1 data in T cell lymphoma with AUTO4 in the second half of 2020
Financial results for third quarter 2019

Cash and equivalents at September 30, 2019 totaled $229.4 million, compared with $247.1 million at September 30, 2018.

Net total operating expenses for the three months ended September 30, 2019 were $35.6 million, net of grant income of $0.3 million, as compared to net operating expenses of $17.1 million, net of grant income of $0.3 million, for the same period in 2018. The increase was due, in general, to the increase in development activity, increased headcount primarily in our development and manufacturing functions, and the cost of being a public company.

Research and development expenses increased to $27.3 million for the three months ended September 30, 2019 from $10.1 million for the three months ended September 30, 2018. Cash costs, which exclude depreciation as well as share-based compensation, increased to $21.6 million from $9.0 million. The increase in research and development cash costs of $12.6 million consisted primarily of an increase of compensation-related costs of $5.2 million primarily due to an increase in employee headcount to support the advancement of our product candidates in clinical development, an increase of $3.6 million in research and development program expenses related to the activities necessary to prepare, activate, and monitor clinical trial programs, including the manufacturing technical transfer activities required for AUTO1 to enable the commencement at the end of 2019 of a registration study in Adult Acute Lymphoblastic Leukemia, an increase of $2.6 million in facilities costs supporting the expansion of our research and translational science capability and investment in manufacturing facilities and equipment, an increase of $0.7 million in telecom and software costs, and an increase of $0.5 million in other costs.

General and administrative expenses increased to $8.6 million for the three months ended September 30, 2019 from $7.3 million for the three months ended September 30, 2018. Cash costs, which exclude depreciation expense as well as share-based expense compensation decreased to $5.6 million from $5.7 million. Compensation related expenses decreased by $0.6 million and IT, telecommunication, and general office expense costs decreased by $0.7 million which were offset by an increase in legal and professional fees of $0.9 million and an increase of $0.3 million in commercial costs.

Net loss attributable to ordinary shareholders was $27.2 million for the three months ended September 30, 2019, compared to $12.9 million for the same period in 2018.

The basic and diluted net loss per ordinary share for the three months ended September 30, 2019 totaled $(0.61) compared to a basic and diluted net loss per ordinary share of $(0.33) for the three months ended September 30, 2018.

Autolus anticipates that cash on hand provides a runway into the second half of 2021.

Conference Call and Presentation Information

Autolus management will host a conference call today, November 7, at 8:30 a.m. EST/ 1:30pm GMT, to discuss the company’s financial results and operational update.

To listen to the webcast and view the accompanying slide presentation, please go to: View Source

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID 5075598. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID 5075598.

MedX Health Corp. Announces Private Placement Closing

On November 7, 2019 MedX Health Corp. ("MedX" or the "Company") (TSX-V:MDX) reported that, pursuant to a non-brokered Private Placement Offering (the "Placement Offering"), it has completed an initial Closing of 1,251,000 Units effective November 4, 2019, to raise $150,120 from accredited investors pursuant to a Private Placement Offering announced on November 1, 2019 (Press release, MedX Health, NOV 7, 2019, View Source [SID1234550679]). Each Unit, priced at $0.12, comprises one fully paid common share and one share purchase warrant; each warrant entitles the holder to purchase one additional share at a price of $0.20 during the period up to two years from the closing date of the placement. The securities issued as a result of the Placement Offering will be restricted from trading for four months following each Closing. The Placement Offering is still open to subscribers, and further subscriptions may be accepted for further Closings. This Closing, and any further Closing of the Placement Offering, is subject to all relevant regulatory and other consents and approvals, including acceptance by the TSX Venture Exchange. In connection with the first Closing, a cash commission of $5,136 was paid and 42,800 Agent’s Warrants were issued.

Following this Closing, MedX has 143,169,762 common shares issued and outstanding.

NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell Carcinoma at SITC 2019

On November 7, 2019 NantKwest Inc. (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported the presentation of results from their Phase 2 trial investigation using aNK, NantKwest’s off-the-shelf natural killer cell-based therapeutic, in combination with N-803, ImmunityBio’s IL-15 superagonist, in patients with advanced refractory metastatic Merkel cell carcinoma (MCC) (NCT03853317) at The 34th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2019) on November 8, 2019 in National Harbor, Maryland. ImmunityBio is an affiliate company of NantKwest (Press release, NantKwest, NOV 7, 2019, View Source [SID1234550678]).

Dr. Shailender Bhatia, Associate Professor of Medical Oncology at the University of Washington/Fred Hutchinson Cancer Research Center, will make an oral presentation entitled "Final results from a phase 2 study using off-the-shelf activated natural killer (aNK) cells in combination with N-803, an IL-15 superagonist, in patients with metastatic Merkel cell carcinoma (MCC)." That study demonstrated long term, durable responses in 2 of 7 patients with advanced refractory MCC. One of these patients achieved a radiologic complete response, and the second a durable partial response with more than 75% tumor regression and no subsequent therapy (response ongoing to date). Both patients with responses in the trial remain alive to date, 29 and 44 months after the initiation of treatment.

Results from this study provide evidence that treatment with aNK cell therapy can stimulate immune responses to checkpoint inhibitors, even in patients that have previously failed treatments using these types of therapies. One heavily pretreated subject refractory to pembrolizumab was rechallenged with this checkpoint inhibitor subsequent to receiving aNK cell therapy resulting in a durable complete response (CR) that is ongoing at this time, 44 months after receipt of first aNK cell infusion.

"We believe the results of this Phase 2 study are testament to the potential of our natural killer cell-based therapeutics to change the cancer treatment paradigm," said Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. "Long term responses in patients with refractory metastatic disease is a remarkable achievement and is supportive of our upcoming trial, which will evaluate NantKwest’s off-the-shelf CD16-targeted haNK cells in combination with N-803 and Pfizer’s avelumab in patients with advanced MCC who are refractory to immune checkpoint inhibitors. We are particularly enthusiastic about the potential of aNK and N-803 to induce sensitization to checkpoint inhibitors, and thus, are evaluating this in our upcoming trial. We remain deeply committed to harnessing the power of immunogenic cell death across a wide range of indications to provide innovative treatments to patients with serious unmet need."

NantHealth Reports 2019 Third-Quarter Financial Results

On November 7, 2019 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported financial results for its third quarter ended September 30, 2019 (Press release, NantHealth, NOV 7, 2019, View Source [SID1234550677]).

"For the 2019 third quarter, the top line for our SaaS business grew significantly over the same quarter last year," said Bob Petrou, Chief Financial Officer, NantHealth. "This performance, largely driven by an expanding customer base and increasing number of covered lives, demonstrates the integral role NantHealth’s SaaS solutions play in providing a continuum of care for payers, providers and, most importantly, the patients we serve. At the companywide level, we have made great progress managing our financial performance and growing gross margin, all resulting in reduced cash burn and enhanced bottom line results."

Software and Services Q3 Highlights:

Clinical Decision Support (Eviti):
Renewed a partnership contract with a leading provider of clinical solutions. The contract has a three-year term and a minimum estimated total value of $38.4 million
Signed an agreement with Wexford Health Sources, one of the nation’s largest correctional healthcare companies, bringing evidence-based standards and value-based oncology care to patients
Renewed an agreement with a large national health plan for federal employees, retirees and their families. Plan members will continue to receive streamlined preauthorization of cancer care
Launched several enhancements designed to provide payers with additional information about care management, including the intended use of brand name drugs and visibility into settings where care is provided. Payers with multiple plans can now permit their users to view multiple dashboards, which saves time by reducing the need for multiple logins and passwords
Received full accreditation from URAC for the Eviti platform. Eviti continues to meet URAC Health Utilization Management standards, valid through September 1, 2022. The designation recognizes those companies abiding by evidence-based standards and value-based care
Payer Engagement (NaviNet):
Added NaviNet’s Authorization Attachment application to the NaviNet implementation for one of the nation’s largest health insurance organizations. This feature ensures providers receive the right supporting documentation to make more informed, timely decisions
Expanded NaviNet Open functionality to provide additional notifications within the Authorization application, enabling users to receive information timely and respond quickly to critical requests, eliminating potential delays in caring for patients
NaviNet’s AllPayer product completed the conversion of 3,602 provider offices, more than 80% of AllPayer customers, from a legacy pricing model which will result in more than $1.0 million of additional annual recurring revenue
Connected Care (VCX, DCX):
Introduced VCX 3.0 (formerly VitalsConX), designed to reduce patient overstays and facilitate faster decision making. VCX 3.0 accelerates automated vital sign capture and provides easy entry of other customized observations at the point of care. Updates include streamlined data validation and a touch-based user interface to document vital signs quickly and easily. VCX 3.0 now supports "smart" patient vital sign monitors, including GE VC150
Announced new Shuttle cable features to help improve data collection, efficiency and accuracy using a medical-grade serial-to-USB interface cable
Signed a contract with Baxter expanding DCX (formerly DeviceConX) medical device driver development, enabling Baxter to connect additional devices to electronic medical record (EMR) systems.
In Q4, at the HIMSS Asia Pacific 2019 meeting, NantHealth led the Interoperability Showcase along with GE Healthcare, AirStrip and iProcedures. Together, the companies showcased how clinicians can spend less time on documentation and more time analyzing data in near real-time to improve patient outcomes
Sequencing and Molecular Analysis – Highlights:

Presented a poster on GPS Cancer at the IASLC (World Lung) meeting in Barcelona. Dr. Hossein Borghaei, Fox Chase Cancer Center, and authors from NantHealth and NantOmics, presented a poster, "222 NSCLC’s Classified by PAM50: Luminal A NSCLC Is a Distinct Subtype with Low TMB and Immune Suppressive TME." The poster concludes NantHealth and NantOmics can use GPS Cancer to identify a unique subset of patients who are likely to be resistant to conventional immune checkpoint inhibitor therapy, using a method that has not previously been well characterized in this clinical setting
Presented a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting. NantHealth and NantOmics, together with investigators from Moffitt Cancer Center, presented a poster, "Differential expression of immunoregulatory molecules and highly-associated cancer genes may provide novel insights into strategic trial design for therapeutics." The poster describes novel associations of immune checkpoint gene expression with cancer related genomic mutations beyond Tumor Mutation Burden (TMB) as a biomarker for immunotherapy response
Business and Financial Highlights

For the 2019 third quarter, total net revenue was $22.4 million, compared with $22.3 million in the 2018 third quarter. On June 7, 2019, the Company completed the divestiture of its home health care services business. Accordingly, financial results for the 2019 third quarter do not include the results of operations from this business, which over the last year averaged approximately $1.5 million of revenue per quarter.
Gross profit increased to $14.0 million, or 63% of total net revenue, compared with $11.1 million, or 50% of total net revenue, for the prior year period. The increase was primarily driven by continued growth of the Company’s higher margin SaaS business and overall cost management.
Selling, general and administrative expenses declined to $15.1 million from $17.0 million in 2018 third quarter. The decrease was mainly driven by ongoing cost management efforts and efficiencies in overall processes.
Research and development expenses decreased to $4.6 million from $4.8 million.
Net loss from continuing operations, net of tax, was $16.4 million, or $0.15 per share, compared with $97.5 million, or $0.89 per share, for the 2018 third quarter.
On a non-GAAP basis, net loss from continuing operations was $7.4 million, or $0.07 per share, down from $10.8 million, or $0.10 per share, for the third quarter of last year. The improvement reflects the company’s ongoing efforts to manage costs, growth of its SaaS business and efficiencies and process improvements.
At September 30, 2019, cash and cash equivalents totaled $9.3 million, an increase of $2.3 million from June 30, 2019.
Conference Call Information and Forward-Looking Statements

Thursday, November 7, 2019, after market close, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the third quarter ended September 30, 2019. The conference call will be available to interested parties by dialing 844-309-3709 from the U.S. or Canada, or 281-962-4864 from international locations, passcode 3294717. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.