On November 4, 2021 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its third quarter ended September 30, 2021 (Press release, NantHealth, NOV 4, 2021, View Source [SID1234594438]).

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"Expansion of our Eviti Connect decision support solution to additional diseases states (beyond oncology) has been a major focus for us this year," said Ron Louks, Chief Operating Officer, NantHealth. "With that in mind, I am pleased to report that, during the third quarter, we signed and are preparing to launch the very first Eviti Connect autoimmune disease program with a key customer and interest in this new offering is strong. This was a significant accomplishment and, when coupled with investments we are making in our network monitoring and management service suite (OpenNMS) and data capabilities (Quadris), we believe these advancements lay the foundation for substantial new growth opportunities for our business.

"On the financial front, net revenue for the 2021 third quarter was lower than the previous quarter, primarily due to timing differences between the expiration of certain contracts and the initiation of others. For the 2021 fourth quarter, we expect net revenue to return closer to our average run rate for this year.

"Also, as announced today in a dedicated press release, we added three senior executives to head our sales, strategy and human resource functions. All are accomplished and experienced leaders, and we look forward to the benefit of their insights as we begin the next stage of our growth."

Software and Services Highlights:

Clinical Decision Support (Eviti):
Continued expansion of services provided through a key Eviti channel partner, with the addition of two new health plans and expect further growth in the fourth quarter with the addition of a large, multi-state customer-owned health insurer
Signed agreement with Care Continuity, Inc., a leader in network integrity and care navigation, to partner on product offerings that improve care logistics management for complex, high risk and chronic diseases, with an initial focus on extending care pathways for Eviti Connect customers and their members (with NaviNet care pathway opportunities to follow)
Dr. Tiffany Avery, NantHealth Chief Medical Officer, was selected to present continuing education session on advancing equity in cancer care at the Oncology Clinical Pathways Congress. The virtual session took place October 1
Launched Eviti Connect 8.6, which includes more robust savings and ROI visualizations for payer customers via expanded reporting that is enabled by our Quadris data analytics capabilities
Payer Engagement (NaviNet and Population Health Management):
In October, signed a multi-year agreement with a new third party administrator that will use NaviNet Open to enhance the services it provides to self-insured health plan customers
Signed three-year renewal with a long-term partner and leading provider of drug authorizations, enabling electronic submission of prior authorization for any drug under any plan, including Medicare and Medicaid
Established a collaboration with Intraprise Systems to bring HIPAA One compliance management solutions to the NaviNet provider network, helping providers meet HIPAA compliance requirements and protect patient data
Launched the new NantHealth Help Center, an innovative platform that provides users with easy access to help and training content, online channels to contact support, and tools to view in progress and resolved support requests
Introduced new Authorization Submission APIs that allow providers to automate and streamline prior authorization requests to connected NaviNet payer customers
Network Monitoring and Management (The OpenNMS Group, Inc.):
Renewed agreements with 12 key customers and expanded services with one of the nation’s largest telecom providers (an existing account), reaffirming the value OpenNMS provides its customers
Continued development and preparation for fourth quarter launch of zero-touch appliances, simplifying the deployment of distributed monitoring capabilities at scale
Business and Financial Highlights

For the 2021 third quarter:

Total net revenue was $14.4 million compared with $18.8 million in Q3 of 2020.
Gross profit was $7.5 million, or 52% of total net revenue, compared with $11.2 million, or 60% of total net revenue, for the prior-year period.
Selling, general and administrative (SG&A) expenses increased to $13.0 million from $12.4 million in the 2020 third quarter.
Research and development (R&D) expenses decreased to $4.6 million from $4.7 million.
Net loss from continuing operations, net of tax, was $10.8 million, or $0.09 per share, compared with $11.0 million, or $0.10 per share, in the 2020 third quarter.
Non-GAAP net loss from continuing operations was $11.5 million, or $0.10 per share, compared with $7.2 million, or $0.07 per share, for the third quarter of 2020.
At September 30, 2021, cash and cash equivalents totaled $45.5 million.
Conference Call Information and Forward-Looking Statements

Later today, 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, 2021. The conference call will be available to interested parties by dialing 800-584-1507 from the U.S. or Canada, or 212-231-2902 from international locations. 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.

On November 4, 2021 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place from December 11-14, 2021 in Atlanta, GA (Press release, Bio-Path Holdings, NOV 4, 2021, View Source [SID1234594437]). In addition, ASH (Free ASH Whitepaper) abstracts will appear in the November supplemental issue of Blood.

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Dr. Maro Ohanian, Associate Professor of the Department of Leukemia at The University of Texas M.D. Anderson Cancer Center, will present the safety and preliminary efficacy data from the ongoing Phase 2 trial of prexigebersen (BP1001), the Company’s lead drug candidate, for the treatment of acute myeloid leukemia.

Details for the presentation are as follows:

Date: Saturday, December 11, 2021
Presentation Time: 5:30 PM – 7:30 PM Eastern Time
Location: Georgia World Congress Center, Hall B5

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster I
Title: Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with High-Risk and Relapsed/Refractory Acute Myeloid Leukemia (AML)

On November 4, 2021 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported third quarter 2021 financial results and provided a business update (Press release, NextCure, NOV 4, 2021, View Source [SID1234594436]).

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"We are pleased to present clinical and biomarker data for our NC318 and NC410 programs at the upcoming SITC (Free SITC Whitepaper) annual meeting," said Michael Richman, NextCure’s president and chief executive officer. "In addition, we will host a virtual research and development update event following the conference on November 15th. The event will also feature Dr. Roy Herbst who will highlight the significant remaining unmet need in the treatment of lung cancer. Dr Herbst is currently a collaborator in the Phase 2 investigator-initiated clinical trial of NC318 in combination with pembrolizumab in patients with advanced non-small cell lung cancer."

Business Highlights and Upcoming Milestones

Published preclinical data pertaining to the NC410 program in the open access journal, Frontiers in Immunology.
Appointed Ellen G. Feigal, M.D., a Partner and Head of the Biologics Practice at NDA Partners LLC, and Anne Borgman, M.D., former Vice President and Global Therapeutic Area Lead, Hematology-Oncology, at Jazz Pharmaceuticals, to the Board of Directors.
Appointed Elizabeth Jaffee, M.D., Ursula Matulonis, M.D., and Weiping Zou, M.D., Ph.D., to its Scientific Advisory Board.
Clinical and biomarker data for NC318 and NC410 programs to be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting on November 10-14, 2021.
Hosting a virtual research and development update event on November 15, 2021, at 4:30 pm EST.
Announced presentations by collaborators at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) on December 11-14, 2021, two research studies evaluating the role of Siglec-15 as a therapeutic target in childhood leukemia and the impact of a LAIR-1 antibody that selectively targets AML stem cells.
Financial Guidance
Based on its current research and development plans, NextCure expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditure requirements into the second half of 2023.

Financial Results for Quarter Ended September 30, 2021

Cash, cash equivalents and marketable securities as of September 30, 2021, were $235.3 million, as compared to $283.4 million as of December 31, 2020. The decrease of $48.1 million primarily reflects cash used to fund operations, to purchase fixed assets, and to repay a term loan.
Research and development expenses were $13.6 million for the quarter ended September 30, 2021, as compared to $12.7 million for the quarter ended September 30, 2020. The increase was driven primarily by clinical-related costs, partially offset by timing of research and manufacturing supply costs.
General and administrative expenses were $4.9 million for the quarter ended September 30, 2020, as compared to $4.7 million for the quarter ended September 30, 2020. The increase was primarily related to personnel-related costs.
Net loss was $17.9 million for the quarter ended September 30, 2021, as compared to $16.4 million for the quarter ended September 30, 2020. The increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses from an increase in headcount.

On November 4, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported financial results for the three months ending September 30, 2021 (Press release, Quanterix, NOV 4, 2021, View Source [SID1234594435]).

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"We are making critical advances across neurology and infectious disease with recent breakthrough device designation for an Alzheimer’s blood test and expanded EUA label for a COVID-19 test by the U.S. FDA," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. "Our Simoa phospho-Tau 181 (pTau-181) blood test is a critical potential aid in the diagnostic evaluation of Alzheimer’s disease, in particular by unlocking the possibility for earlier, more accessible, higher-throughput, non-invasive diagnosis to enable advances in neuro-diagnostic therapies. Furthermore, our label expansion for our Simoa SARS-CoV-2 N Protein Antigen Test demonstrates yet another example of Simoa’s potential for achieving asymptomatic and low-invasive clinical testing."

Third Quarter 2021 Financial Highlights

Key financial results for the third quarter of 2021 are shown below:

Q3 GAAP total revenue, which includes grant revenue of $1.0M, was $27.7M versus prior year Q3 of $31.4M; prior year Q3 included one-time license revenue of $11.2M and grant revenue of $1.9M;
Q3 non-GAAP total revenue was $26.7M versus prior year Q3 non-GAAP total revenue of $18.3M, an increase of 46%;
Q3 GAAP product revenue was $20.7M versus prior year Q3 of $11.7M, an increase of 77%;
Q3 GAAP service and other revenue was $5.9M versus prior year Q3 of $6.6M, a decrease of 10% over a strong 2020 driven by one time COVID-related services; our two year CAGR (Q319 – Q321) for services is 18%; and
Q3 GAAP gross margin was 55.1% versus prior year Q3 GAAP gross margin of 67.2%; Q3 non-GAAP gross margin was 54.8% versus prior year Q3 non-GAAP gross margin of 51.5%.
YTD 2021 Financial Highlights

Key financial results for YTD 2021 are shown below:

YTD GAAP total revenue, which includes grant revenue of $4.2M, was $80.3M versus prior year YTD of $60.2M; prior year YTD included one-time license revenue of $11.2M and grant revenue of $1.9M;
YTD non-GAAP total revenue was $76.0M versus prior year YTD non-GAAP total revenue of $47.1M, an increase of 61%;
YTD GAAP product revenue was $57.6M versus prior year YTD of $28.3M, an increase of 104%;
YTD GAAP service and other revenue was $18.0M, versus prior year YTD of $18.6M, a decrease of 4% over a strong 2020 driven by one time COVID-related services; our two year CAGR (YTD19 – YTD21) for services is 24%; and
YTD GAAP gross margin was 56.6% versus prior year YTD GAAP gross margin of 55.0%; YTD non-GAAP gross margin was 56.1% versus prior year YTD non-GAAP gross margin of 48.4%.
For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" below.

Third Quarter 2021 Business Highlights

Quanterix’ Simoa phospho-Tau 181 (pTau-181) blood test was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s disease;
The FDA expanded the Emergency Use Authorization (EUA) label for Quanterix’ Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. The expanded label established this test as the first antigen test authorized for use with saliva samples;
Quanterix’ Simoa HD-X technology and assays were used to measure pTau-217 using antibodies developed by Eli Lilly and Company for its Phase 2 TRAILBLAZER-ALZ study, which was presented by Lilly at the Alzheimer’s Association International Conference (AAIC) 2021;
Hosted the webinar: COVID-19 Testing in a Residential University Setting with leading pathologist Dr. John Roback, M.D., Ph.D., Professor of Pathology and Laboratory Medicine, Executive Vice-Chair for Clinical Operations, and Medical Director for Emory Medical Laboratories, that discussed implementation of a broad SARS-CoV-2 screening program for Emory students, faculty and staff, enabling a safe return to campus-based learning. To date, Emory has run over 120,000 tests using the Simoa SARS-CoV-2 N Protein Antigen Test;
Co-hosted the webinar, Cytokine Profiles and Personalized Therapeutics in COVID-19 Patients with Guy Gorochov, M.D., Ph.D., Professor of Medicine, Head of the Dept. of Immunology and Co-Director CIMI Research Centre, Sorbonne University/INSERM and Laurel Provencher, Ph.D., Sr. Director of Strategic Collaborations, Quanterix, who discussed recently published observations that describe distinct cytokine profiles and COVID-19 severity and mortality;
Kevin Hrusovsky delivered a presentation at the Second Annual Biomarkers for Alzheimer’s Disease Conference on Aug. 26 with Nicholas Ashton, Ph.D., Assistant Professor, Department of Psychiatry & Neurochemistry, University of Gothenburg. The presentation discussed key features of assay development of plasma pTau-181 and pTau-231 on the Simoa platform, provided an overview of plasma pTau across the AD continuum and featured head-to-head comparisons of pTau plasma biomarkers;
Delivered a presentation at the Precision Medicine Leaders’ Summit on transforming cancer detection with biomarker technology; and
Quanterix Simoa technology was highlighted in 125 new publications, bringing total Simoa-specific inclusions to more than 1,480 publications.
Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on November 4, 2021 at 4:30 p.m. EDT. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 3488875.

A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

Use of Non-GAAP Financial Measures

To supplement the Company’s financial statements presented on a GAAP basis, the Company has provided certain non-GAAP financial measures, including non-GAAP revenue and non-GAAP gross margin. Management uses these non-GAAP measures to evaluate the Company’s operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such measures are important in comparing current results with prior period results and are useful to investors and financial analysts in assessing the Company’s operating performance. The non-GAAP financial information presented here should be considered in conjunction with, and not as a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth below.

On November 4, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Credit Suisse 30th Annual Healthcare Conference (Press release, Quest Diagnostics, NOV 4, 2021, View Source [SID1234594434]). Mark Guinan, Executive Vice President and CFO, will discuss the company’s vision, goals, and capital deployment strategies. The presentation is scheduled for Tuesday, November 9, 2021, at 9:40 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until December 9, 2021.