On November 3, 2022 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, 2022 (Press release, NantHealth, NOV 3, 2022, View Source [SID1234623094]).

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"Net revenue was $16.6 million for the third quarter of 2022, representing the fourth consecutive quarter of top-line growth," said Ron Louks, Chief Operating Officer, NantHealth. "Moreover, our gross profit of $9.7 million and gross margin of 58 percent for the quarter were the highest since the fourth quarter of 2020.

"We expect to continue the positive momentum generated over the last several quarters. Recently, we signed a new customer, a leading provider of technology-enabled payment integrity, eligibility and related analytics services, to a four-year agreement for our NantHealth solutions. Importantly, we are also benefiting from a broadened product portfolio, with existing customers appreciating the value of our multiple solutions and services."

Software and Services Q3 Highlights:

Clinical Decision Support and Pre-Authorization (Eviti):
In October, secured a three-year contract extension with a large national commercial insurer providing coverage to over two million of their Medicaid members across multiple states. This client has opted to continue bringing unparalleled value to their operations by using Eviti Connect, and has used this renewal period to increase their solution set to include formulary redirection, further enabling value-based care
Announced Eviti Connect platform once again earned full URAC accreditation for Health Utilization Management through 2025. This designation demonstrates the highest level of commitment to quality healthcare
Maryland Physicians Care signed a two-year renewal agreement, ensuring it continues to receive a unique and tailored solution for its members with autoimmune diseases
Added new capability to Eviti Connect, which allows payer clients to comply seamlessly with state-mandated preferred drug lists, eliminating the need for manual reviews and secondary processing when those preferred drugs are prescribed
Payer Engagement (NaviNet):
Secured an agreement with an existing customer, one of America’s leading health insurance organizations, which added 750,000 new members to NaviNet
Went live with NaviNet Open Prior Authorization for a key customer. This capability is expected to streamline workflows and data collection to enable automated decisions and reduced manual processes. The initial deployment has been completed with further roll outs planned in Q4
Added new platform functionality to speed up the prior authorization process, enabling more timely patient care. Updates include the ability for health plans to add direct-to-provider information within the request
Network Monitoring and Management (The OpenNMS Group, Inc.):
Completed shipment of small form factor OpenNMS mini appliances for user testing. Highly optimized for secure, scalable, and reliable distributed monitoring via the OpenNMS Minion component, these hardware appliances provide visibility into remote or private areas of enterprise networks
Made significant progress toward the development of a capability that will let customers monitor infrastructures built using VMware SD-WAN. This initiative marks a significant milestone in the OpenNMS Managed Service Provider (MSP) support program
Delivered several service engagements positioning OpenNMS as strategically significant within the clients’ IT organizations. Clients included a large national retail chain, an entertainment streaming service, and a top wireless communication provider
Third quarter Financial Results: 2022 vs 2021

For the 2022 third quarter:

Total net revenue was $16.6 million compared with $14.4 million.
Gross profit was $9.7 million, or 58% of total net revenue, compared with $7.5 million, or 52% of total net revenue.
Selling, general and administrative (SG&A) expenses increased to $16.6 million from $13.0 million.
Research and development (R&D) expenses increased to $6.3 million from $4.6 million.
Net loss attributable to NantHealth was $13.7 million, or $0.12 per share, compared with $10.8 million, or $0.09 per share.
On a non-GAAP basis, net loss from continuing operations was $14.0 million, or $0.12 per share, compared with $11.5 million, or $0.10 per share.
At September 30, 2022, cash and cash equivalents totaled $0.6 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, 2022. The conference call will be available to interested parties by dialing 800-942-2493 from the U.S. or Canada, or 212-231-2931 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 3, 2022 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 2022 financial results (Press release, NextCure, NOV 3, 2022, View Source [SID1234623093]).

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"Based on current efficacy data, we have decided to discontinue our clinical development of NC318. We will continue to support Yale University through its ongoing investigator initiated trial of NC318 in combination with pembrolizumab in lung cancer patients," said Michael Richman, NextCure’s president and chief executive officer. "We will focus our development efforts on the LAIR programs, including the recently initiated Phase 1b/2 combination trial of NC410 in solid tumors and the Phase 1 trial of NC525 that is expected to start in the first quarter of 2023. In addition, we have now initiated the NC762 expansion trial. These decisions are expected to add an additional 15 months to our cash runway and extend it into mid-2025."

Business Highlights

NC318 (S15 mAb)

●Based on the totality of the NC318 monotherapy data, including no responses in the amended Phase 2 portion of the trial, we have decided to discontinue development of our NC318 program.
●We will support Yale University’s ongoing NC318 investigator initiated combination trial.

NC410 (LAIR-2 fusion)

●Completed the Phase 1a dose escalation portion of the monotherapy trial and demonstrated that NC410 was safe and well tolerated.
●Initiated a Phase 1b/2 trial to evaluate NC410 in combination with pembrolizumab in patients with immune checkpoint refractory or naïve solid tumors.

NC525 (LAIR-1 mAb)

●Filed an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) and have received clearance to proceed with a Phase 1 trial.
●Plan to initiate a Phase 1 trial in the first quarter of 2023.
NC762 (B7-H4 mAb)

●Completed the Phase 1a dose escalation portion of the trial and demonstrated that NC762 was safe and well tolerated.
●Initiated the Phase 1b expansion trial.

Financial Guidance

●The decisions related to discontinuing NC318 and prioritizing NC410 in combination therapy are expected to add an additional 15 months to our cash runway.
●NextCure now expects its existing cash, cash equivalents and marketable securities will enable it to fund operating expenses and capital expenditures into mid-2025.

Financial Results for Quarter Ended September 30, 2022

●Cash, cash equivalents, and marketable securities, excluding restricted cash as of September 30, 2022, were $169.2 million as compared to $219.6 million as of December 31, 2021. The decrease of $50.4 million primarily related to cash used to fund operations, cash used to purchase fixed assets, and changes in the fair value of our marketable securities.
●Research and development expenses were $13.5 million for the quarter ended September 30, 2022, as compared to $13.6 million for the quarter ended September 30, 2021.
●General and administrative expenses were $5.7 million for the quarter ended September 30, 2022, as compared to $4.9 million for the quarter ended September 30, 2021. The increase of $0.8 million primarily related to higher personnel-related costs.
●Net loss was $18.9 million for the quarter ended September 30, 2022, as compared with a net loss of $17.9 million for the quarter ended September 30, 2021. The change in net loss from the previous year’s quarter was primarily due to higher general and administrative expenses and lower interest income.

On November 3, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the third quarter ended September 30, 2022 and provided an update on recent developments (Press release, IGM Biosciences, NOV 3, 2022, View Source [SID1234623092]).

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"We have made substantial progress in advancing our IgM platform in the third quarter, particularly in expanding the body of evidence underlying our T cell engager portfolio for hematologic malignancies and in generating additional clinical data for IGM-8444. We continue to believe that each of our T cell engager product candidates has the potential to change the treatment paradigm in its respective indication. Notably, we are excited to share the first insight into the preclinical profiles of IGM-2644, our CD38 x CD3 bispecific IgM antibody, and IGM-2537, our CD123 x CD3 bispecific IgM antibody, during poster presentations at the upcoming ASH (Free ASH Whitepaper) meeting in December," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "Additionally, today we are providing an update from the Phase 1 dose escalation trial of imvotamab in relapsed and/or refractory NHL describing its durable benefit for relapsed and/or refractory NHL patients. We look forward to sharing an initial Phase 2 efficacy and safety update for imvotamab and an initial efficacy and safety update on the FOLFIRI combination for IGM-8444 in Q1 2023."

Pipeline Updates

Imvotamab (CD20 x CD3)

Biomarker data from the Phase 1 trial evaluating imvotamab, the Company’s novel IgM T cell engaging bispecific antibody, selected for presentation at 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually and in-person in New Orleans, Louisiana, December 10-13, 2022. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "Pharmacodynamics and Biomarker Correlates of Imvotamab (IGM-2323), the First-in-Class CD20 x CD3 Bispecific IgM Antibody with Dual Mechanisms of Action, in Patients with Advanced B Cell Malignancies."

Biomarker data obtained from patients in dose escalation cohorts will be presented illuminating the relationship between T cell levels and response as well as pharmacodynamic data confirming T cell dependent (TDCC) and complement dependent (CDC) mechanisms of action for imvotamab in patients. Biomarker data (minimal residual disease data) to support durability of response will also be presented.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

Clinical development of imvotamab advances. IGM today provided an update on response duration from the Phase 1 dose escalation study of imvotamab in patients with relapsed and/or refractory (R/R) non-Hodgkin’s lymphoma (NHL).

In data previously reported at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, imvotamab showed a 50% complete response (CR) rate at the likely optimal 100 mg dose (n=10). Of the 28 patients treated in the titration dosing cohorts at that time, cytokine release syndrome was seen in less than 20% of patients.

Seven of eight complete response patients were tumor free after more than 1 year as of the data cut-off of August 31, 2022, and as of the data cut-off, the median overall duration of response in these patients had not yet been reached. All DLBCL patients with a complete response reported as of ASH (Free ASH Whitepaper) 2021 remained in complete response. Seven responding patients switched from weekly to Q3W therapy and all remain on study with sustained responses.

IGM expects to provide an initial Phase 2 efficacy and safety update for imvotamab in the first quarter of 2023.

Announced clinical trial collaboration and supply agreement with ADC Therapeutics SA. IGM expects to initiate clinical testing evaluating the combination of imvotamab and ZYNLONTA (loncastuximab tesirine-lpyl), ADC Therapeutics’ CD19-directed antibody drug conjugate (ADC), for the treatment of patients with R/R NHL in the first quarter of 2023.
IGM-2644 (CD38 x CD3)

Preclinical data for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, selected for poster presentation at 2022 ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "IGM-2644, a Novel CD38 x CD3 Bispecific IgM T Cell Engager Demonstrates Potent Efficacy on Myeloma Cells with an Improved Preclinical Safety Profile."

Preclinical data will be presented that highlights the potency of IGM-2644 with potential activity in daratumumab resistant tumors and a preclinical safety profile with lower cytokine release and reduced T cell fratricide compared to other CD38 x CD3 bispecific T cell engagers.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

Phase 1 trial expected to initiate in first quarter of 2023. IGM expects to initiate a Phase 1 trial of IGM-2644 in multiple myeloma in the first quarter of 2023, subject to IND clearance.
IGM-2537 (CD123 x CD3)

Preclinical data for IGM-2537, the Company’s CD123 x CD3 bispecific IgM antibody, selected for poster presentation at 2022 ASH (Free ASH Whitepaper) Annual Meeting and Exposition. The results will be presented on Sunday, December 11, 2022, at 6:00 p.m. CT, in a poster presentation titled "CD123 Directed IgM Antibody-based T-cell Engager, IGM-2537, Demonstrates Potent in vitro and in vivo Activity with Minimal Cytokine Release."

Preclinical data will be presented highlighting potent in vitro and in vivo activity with minimal cytokine induction providing initial evidence of a favorable preclinical safety profile for a CD123 directed IgM-based T cell engager.

The ASH (Free ASH Whitepaper) abstract is available through the ASH (Free ASH Whitepaper) online meeting program.

IND application expected to be filed next year. IGM expects to file an IND application for IGM-2537 in acute myeloid leukemia in 2023.

IGM-8444 (DR5)

Clinical development of IGM-8444 advances. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase 1 clinical trial in multiple combination treatment regimens in subjects with relapsed and/or refractory solid and hematologic cancers.

Expansion dosing ongoing in the FOLFIRI combination. IGM continues to enroll patients in an expansion of its 3 mg/kg FOLFIRI combination dose cohort in colorectal cancer patients, and it has recently further expanded this 3 mg/kg dose cohort to include treatment with IGM-8444 in combination with both bevacizumab and FOLFIRI in colorectal cancer patients. After completion of these 3mg/kg expansion cohorts, IGM expects to begin expansion of its 10 mg/kg FOLFIRI combination dose cohort. The Company expects to provide an initial efficacy and safety update on colorectal cancer patients treated with 3 mg/kg of IGM-8444 plus FOLFIRI in the first quarter of 2023.

Dosing ongoing in the fourth birinapant dose cohort. IGM is currently enrolling patients in the fourth planned birinapant combination dose escalation cohort.

IGM-7354 (IL-15 x PD-L1)

Phase 1 trial to initiate in the first quarter of 2023. IGM reported that it expects to dose the first patient in the Phase 1 trial for IGM-7354, IGM’s targeted IL-15 IgM antibody for the treatment of patients with solid and hematologic malignancies, in the first quarter of 2023, subject to IND clearance.

Preclinical data to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The poster, titled "IGM-7354, an anti-PD-L1/IL-15 IgM immunocytokine, activates and expands NK cells and effector memory CD8+ T cells in vivo" will be made available beginning at 9:00 a.m. ET on Thursday, November 10, 2022, through the SITC (Free SITC Whitepaper) online meeting program.

Corporate Updates

Albert Candia, Ph.D. appointed Senior Vice President of Preclinical Sciences. Dr. Candia brings over 22 years of biotechnology experience to IGM in both research and development in a variety of therapeutic areas and drug modalities. Prior to joining IGM, he was Vice President of Bioanalytical Development at Nektar Therapeutics, leading cross functional teams supporting clinical development and chemistry, manufacturing and control. Dr. Candia has also held previous positions at Dynavax Technologies and Xencor, where he oversaw IND enabling, translational and biomarker activities. Dr. Candia received his B.A. in Biology and Chemistry from Bucknell University and a Ph.D. in Cell Biology from Vanderbilt University School of Medicine.
Third Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of September 30, 2022 were $469.1 million, compared to $229.5 million as of December 31, 2021.

Collaboration Revenue: For the third quarter of 2022, collaboration revenue was $0.3 million, compared to no revenue for the same period in 2021.

Research and Development (R&D) Expenses: For the third quarter of 2022, R&D expenses were $48.2 million, compared to $34.2 million for the same period in 2021.

General and Administrative (G&A) Expenses: For the third quarter of 2022, G&A expenses were $12.7 million, compared to $10.0 million for the same period in 2021.

Net Loss: For the third quarter of 2022, net loss was $58.0 million, or a loss of $1.32 per share, compared to a net loss of $44.2 million, or a loss of $1.32 per share, for the same period in 2021.

2022 Financial Guidance

IGM is updating its financial guidance and expects to end 2022 with a balance of more than $410 million in cash and investments and full year GAAP operating expenses of $240 million to $245 million including estimated non-cash stock-based compensation expense of approximately $45 million. IGM estimates full year collaboration revenue of approximately $1 million related to the Sanofi agreement.

On November 3, 2022 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, reported the acceptance of two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) 2022 Annual Congress, taking place in Geneva, Switzerland and online from December 7-9, 2022 (Press release, Poseida Therapeutics, NOV 3, 2022, View Source [SID1234623063]).

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Details of the presentations are as follows. The full abstracts will be made available on the ESMO (Free ESMO Whitepaper) website on December 1, 2022 at 12:05 AM CET.

About P-MUC1C-ALLO1
P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in Phase 1 development for multiple solid tumor indications. Poseida believes P-MUC1C-ALLO1 has the potential to treat a wide range of solid tumors derived from epithelial cells, such as breast, colorectal, lung, ovarian, pancreatic and renal carcinomas, as well as other cancers expressing a cancer-specific form of the Mucin 1 protein, or MUC1-C. P-MUC1C-ALLO1 is designed to be fully allogeneic, with genetic edits to eliminate or reduce both host-vs-graft and graft-vs-host alloreactivity. Poseida has demonstrated the elimination of tumor cells to undetectable levels in preclinical models of both breast and ovarian cancer. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT05239143.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate, partnered with Roche, targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma in Phase 1 development. In vitro and in vivo P-BCMA-ALLO1 preclinical studies, showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior anti-tumor efficacy compared to an autologous CAR-T therapy. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.

On November 3, 2022 Acepodia, a clinical-stage biotechnology company developing first-in-class cell therapies with its unique antibody-cell conjugation (ACC) technology to address gaps in cancer care, reported the upcoming poster presentation of new preclinical data for ACE1831, a gamma delta 2 T cell therapy being developed as a treatment for non-Hodgkin’s lymphoma (Press release, Acepodia, NOV 3, 2022, View Source [SID1234623062]). The company will present this data at the 37th annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held in Boston, MA, from November 8 to 12, 2022.

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The poster presentation will showcase data demonstrating that ACE1831 is able to target cancer cells, overcome tumor defenses, and deliver a potent, cancer-killing cellular payload.

Details on the presentation and session information are provided below:

Presentation details

The poster presentation will be accessible in person and virtually. All accepted abstracts will be published in a Supplement to the Journal for ImmunoTherapy of Cancer (JITC).

"Acepodia’s unique Antibody-Cell Conjugation (ACC) technology platform is inherited from the lab of Dr. Carolyn Bertozzi, 2022 Nobel Prize laureate in Chemistry, where she pioneers work in the development of biorthogonal chemistry and moves click chemistry into living organisms. Antibody-Cell Conjugation technology uses this live-cell compatible chemistry to link any tumor-targeting antibody to the surface of human immune cells. This powerful, new approach to cell therapy development has the potential to enhance the ability of γδ2 T cells to recognize and engage the tumor by unlocking multiple receptor signaling pathways. This could potentially allow ACC-γδ2 T therapies to overcome the challenges that have prevented cell therapies from effectively targeting solid tumors," said Sonny Hsiao, Ph.D., chief executive officer and co-founder of Acepodia. "We plan to continue developing novel off-the-shelf cell therapy that leverage our unique ACC technology platform, which can be applied to a variety of immune effector cells, and we look forward to advancing our ACE1831 into phase 1 clinical study in 2022."

About Gamma-Delta T Cells
Acepodia’s gamma delta T cell program harnesses the unique properties of gamma delta T cells to develop a new class of off-the-shelf cell therapies for the treatment of cancer. Gamma delta T cells have characteristics of both the innate and adaptive immune systems that make them an ideal chassis for the development of cell therapies. This cell type can recognize and attack cancerous cells as well as coordinate a broad antitumor immune response by recruiting other immune factors and cells to the site of disease. Gamma delta T cells have also been shown to preferentially traffic to distinct tissues and could be ideally suited for more targeted treatment of certain types of cancers.