NantHealth Reports 2021 Third Quarter Financial Results

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.

Shattuck Labs to Host Conference Call and Webcast Highlighting Data Presented at the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 4, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported it will host a live webcast presentation highlighting the clinical data being presented at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) on Friday, November 12, 2021 at 8:00 a.m. ET (Press release, Shattuck Labs, NOV 4, 2021, https://ir.shattucklabs.com/news-releases/news-release-details/shattuck-labs-host-conference-call-and-webcast-highlighting-data [SID1234594454]).

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The event will be led by Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck, and will include presentations by Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck and Andrew Neill, M.B.A., Chief Financial Officer of Shattuck. During the event, the company will highlight dose-escalation data for SL-172154 (SIRPα-Fc-CD40L), its lead bi-functional fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor, in platinum-resistant ovarian cancer patients, and dose-escalation data for SL-279252 (PD1-Fc-OX40L), which is designed to simultaneously inhibit the PD-1/PD-L1 interaction and activate the OX40 receptor, in patients with advanced solid tumors or lymphoma. Members of Shattuck leadership will be available to answer questions at the end of the event.

The live call may be accessed by dialing (833) 614-1555 (domestic) or (516) 575-8754 (international) and entering the conference code: 4068596. The live and archived webcast will be available on the Events & Presentations section of the Company’s website. A replay of the webcast will be archived for up to 90 days following the presentation date.

XOMA Earns $35 Million Milestone Payment as Anti-TGFβ Antibody Enters Phase 3 Clinical Study in Metastatic Pancreatic Cancer

On November 4, 2021 XOMA Corporation (Nasdaq: XOMA) reported NIS793, an anti-TGFβ monoclonal antibody licensed from the Company, has advanced to the Phase 3 development stage, triggering a $35 million milestone payment from Novartis (Press release, Xoma, NOV 4, 2021, View Source [SID1234594490]). The Phase 3 trial (NCT04935359) is designed to assess the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). In July, Novartis announced the U.S. Food and Drug Administration has granted Orphan Drug Designation to NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer.

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"Pancreatic cancer claims far too many lives every year, and we appreciate that Novartis chose to pursue it as the first indication for late-stage development with NIS793. We are grateful to the patients and their families who are participating in all of the NIS793 clinical studies," stated Jim Neal, Chief Executive Officer of XOMA. "NIS793 represents one of several important assets in our partner-funded portfolio. This $35 million milestone gives us additional capital to acquire the rights to potential future milestone and royalty economics from biotech companies who can then use the capital to pursue their goal of curing a disease or condition by advancing their clinical development activities."

More information about the NIS793 Phase 3 clinical study, NCT04935359, titled "Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)" can be found at ClinicalTrials.gov.

Under the terms of the 2015 anti-TGFβ development and commercialization agreement with Novartis, XOMA has the potential to earn up to $410 million in additional milestone payments. Should Novartis receive regulatory approval to commercialize NIS793, XOMA will receive tiered royalties on net product sales that range from mid-single digit to low double digits.

NIS793 is an investigational compound. Efficacy and safety have not been established. There is no guarantee that NIS793 will become commercially available.

Actinium Announces Completion of Enrollment of Actimab-A CLAG-M Combination Trial in Patients with Relapsed or Refractory Acute Myeloid Leukemia Fit for Induction Therapy

On November 4, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that the Phase 1 trial studying Actimab-A with the salvage chemotherapy CLAG-M in patients with relapsed or refractory acute myeloid leukemia (r/r AML) who are fit for intensive therapy has completed the planned dose escalation and patient enrollment. Patients in the fourth and final dose escalation cohort received 1.0 μCi/kg of Actimab-A with the standard CLAG-M dose regimen (Press release, Actinium Pharmaceuticals, NOV 4, 2021, View Source [SID1234594506]). This novel combination trial is being conducted at the Medical College of Wisconsin. Updated Phase 1 data is expected will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December and Actinium expects to provide an update on the future clinical development of this combination by year end.

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Actimab-A CLAG-M combination data was presented at ASH (Free ASH Whitepaper) 2020 from the first three dose cohorts, which highlighted:

100% remission rate (CR/CRi) in patients receiving 0.75 μCi/kg of Actimab-A with CLAG-M
83% remission rate in patients who received 3 or fewer lines of prior treatment
70% of patients achieving a remission were MRD negative
67% of patients in the study achieved a remission including patients receiving 0.25 and 0.50 μCi/kg of Actimab-A, which has shown to be subtherapeutic as a single agent in prior studies
All patients had intermediate (N=5, 33%) or adverse (N=10, 67%) cytogenetics
Patients had a median of 2 prior therapies (range:1- 5) including prior Venetoclax/HMA (N=7,47%) or bone marrow transplant (N=8, 53%)
These results compare favorably to outcomes with CLAG-M as a single agent, which was shown in a separate study to have a 55% overall response rate and a 39% MRD negativity rate.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "This novel combination has produced promising data with high rates of remission and MRD negativity with an acceptable safety profile thus far. Despite multiple new drug approvals for patients with AML, including several targeted agents, outcomes for patients with relapsed or refractory AML remain poor, especially those with adverse molecular or cytogenetic features. Actimab-A enables the treatment of AML with radiation at a cellular level, which is a novel mechanism not achievable with traditional external beam radiation given the diffuse nature of blood cancers like AML. Given the sensitivity of AML and other blood cancers to radiation, we are optimistic in its potential to improve patient outcomes. We hypothesized that the combination of Actimab-A with CLAG-M would be tolerable given the non-overlapping mechanisms of action and lead to higher and deeper remissions. We have been very pleased with the data from the trial to date and look forward to advancing this novel combination once we have reviewed the data from all dose cohorts, including the data to be presented at ASH (Free ASH Whitepaper) in December."

Legend Biotech Showcases Updated and New Data from Comprehensive BCMA CAR-T, Cilta-Cel, Program and First Preclinical Results for Tri-specific CAR-T at 2021 ASH

On November 4, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that 12 company-sponsored studies were accepted for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Legend Biotech, NOV 4, 2021, View Source [SID1234594523]). These include two oral presentations and 10 poster presentations .

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Presentation highlights include updates from the CARTITUDE clinical development program for the investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Presentations will detail longer-term follow-up data and new sub-group analysis results from the Phase 1b/2 CARTITUDE-1 study as well as adjusted indirect comparison of CARTITUDE-1 patient outcomes relative to standard-of-care therapies in real-world clinical practice from the LocoMMotion study. First data release from Cohort B and longer-term follow-up data from Cohort A of the CARTITUDE-2 study in earlier lines of treatments will be presented.

Additionally, Legend will share the first preclinical in vivo data on its novel tri-specific single-domain antibody (VHH) CAR-T (LCAR-AIO). LCAR-AIO targets three antigens—CD19, CD20 and CD22—with the potential for development as a treatment for patients with relapsed B cell lymphoma and prior CD19 CAR-T therapies.

"The new and updated data from the CARTITUDE-1 and CARTITUDE-2 studies show that cilta-cel continues to provide early, deep and durable responses, even in high-risk patients," said Ying Huang, PhD, CEO and CFO of Legend Biotech. "What’s also encouraging is the new preclinical data from our novel tri-specific VHH CAR-T, which was designed and developed by Legend. This trispecific CAR-T exemplifies our team’s ability to discover novel mechanisms of action by screening and optimizing antibodies in house."

A select list of abstracts from the meeting can be found below.

ASH Presentations (December 11-14, 2021)

Abstract No.

Title

INFO

Abstract #549
Oral

Updated Results From CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients with Relapsed/Refractory Multiple Myeloma

Session Title: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Date/Time: Sunday, December 12, 2021 4:30 PM – 6:00 PM EST

Presentation time: 5:00 PM EST

Room: Georgia World Congress Center, Hall C2-C3

Abstract #550

Oral

Ciltacabtagene Autoleucel for Triple-Class Exposed Multiple Myeloma: Adjusted Comparisons of CARTITUDE-1 Patient Outcomes Versus Therapies from Real-World Clinical Practice from the LocoMMotion Prospective Study

Session Title: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Date/Time: Sunday, December 12, 2021 4:30 PM – 6:00 PM EST

Presentation time: 5:15 PM EST

Location: Georgia World Congress Center, Hall C2-C3

Abstract#3938

Poster

Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 Subgroup Analysis

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #2812

Poster

Anakinra Targeting Cytokine Release Syndrome Associated with Chimeric Antigen Receptor T-cell Therapies

Session Title: 704. Cellular Immunotherapies: Clinical: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #3866

Poster

Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T-cell Therapy, in Lenalidomide-Refractory Patients with Progressive Multiple Myeloma After 1–3 Prior Lines of Therapy: Updated

Results From CARTITUDE-2

Session Title: 704. Cellular Immunotherapies: Clinical: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #2910

Poster

CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T Cell (CAR T) Therapy, in Patients with Multiple Myeloma and Early Relapse After Initial Therapy

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1835

Poster

Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel vs VRd Followed by Lenalidomide and Dexamethasone (Rd) Maintenance in Patients with Newly Diagnosed Multiple Myeloma Not Intended for Transplant: A Randomized, Phase 3 Study (CARTITUDE-5)

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM – 7:30 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #3057

Poster

LocoMMotion: A Prospective, Non-interventional, Multinational Study of Real-life Current Standards of Care in Patients with Relapsed/Refractory Multiple Myeloma Who Received ≥3 Prior Lines of Therapy

Session Title: 905. Outcomes Research—Lymphoid Malignancies: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1676

Poster

Meta-analysis of Ciltacabtagene Autoleucel versus Physician’s Choice in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Session Title: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM – 7:30 PM

Location: Georgia World Congress Center, Hall B5

Abstract #4075

Poster

Real-World Outcomes for Standard-Of-Care Treatments in Patients with Relapsed/Refractory Multiple Myeloma

Session Title: 905. Outcomes Research—Lymphoid Malignancies: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM – 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1932

Poster

Considerations for optimal administration of Chimeric Antigen Receptor (CAR) T-Cell therapy programs: a multi-stakeholder qualitative analysis

Session Title: 902. Health Services Research—Lymphoid Malignancies: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM – 7:30 PM

Location: Georgia World Congress Center, Hall B5

Abstract #1700

Poster

Tri-specific CD19xCD20xCD22 VHH CAR-T cells (LCAR-AIO) eradicate antigen-heterogeneous B cell tumors, enhance expansion, and prolong persistence in preclinical in vivo models

Session Title: 703. Cellular Immunotherapies: Basic and Translational: Poster I

Date: Saturday, December 11, 2021 5:30-7:30 PM

Location: Georgia World Congress Center, Hall B5

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed or refractory with multiple myeloma, who previously received a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and who had disease progression on or after the last regimen.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 antibody.

About CARTITUDE-2

CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings. Cohort A included patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. Cohort B included patients with early relapse after initial therapy that included a PI and IMiD. The primary objective was percentage of patients with negative minimal residual disease (MRD).2

About CARTITUDE-5

CARTITUDE-5 (NCT04923893) is a Phase 3 open-label study of bortezomib, lenalidomide, and dexamethasone (VRd) followed by cilta-cel vs. VRd followed by Rd maintenance, in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy.

About LocoMMotion

LocoMMotion (NCT04035226) is a prospective non-interventional study evaluating the safety and efficacy of real-life standard-of-care treatments under routine clinical practice over a 24-month period in patients with RRMM. This study aims to understand the effectiveness of current standards of care in heavily pretreated patients with RRMM (reflecting real-world practice in the patient population progressing after PIs, IMiDs and anti-CD38 antibodies).

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections. 8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.