On November 9, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results, operational highlights and recent corporate developments for the third quarter ended September 30, 2023 (Press release, In8bio, NOV 9, 2023, View Source [SID1234637372]).

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"We have continued to execute and to make impressive clinical progress across the breadth of our pipeline, which we shared at our recent Research & Development Day," said William Ho, CEO and co-founder of IN8bio. "Having completed enrollment in the dose escalation portion of the Phase 1 trial of INB-100 in hematologic malignancies and initiated enrollment for the Phase 2 trial of INB-400 in newly diagnosed glioblastoma, we are making strides towards our mission of exploring the full potential of gamma-delta T cells as a much-needed treatment option for cancer patients. We are encouraged by the positive data we have seen thus far and are excited to share additional clinical updates on our INB-100 and INB-200 programs at the upcoming SNO and ASH (Free ASH Whitepaper) meetings."

Business Highlights and Recent Developments

Presented two posters reporting biologic correlative data from the ongoing Phase 1 clinical trial of INB-200 in GBM and preclinical data on IN8bio’s iPSC gamma-delta T cell platform at SITC (Free SITC Whitepaper). The data presented from the INB-200 trial demonstrate the potential of single and repeat doses of DeltEx drug-resistant immunotherapy (DRI) to induce T cell persistence and sustained immune responses. Updated patient, enrollment and survival data from the ongoing INB-200 study will be presented at the SNO Annual Meeting on November 17, 2023. Data from IN8bio’s iPSC platform demonstrate the ability to kill multiple cancer types including ovarian cancer, GBM, CML and AML cell lines along with the potential to generate billions of iPSC-derived Vδ1+ T cells.

Completed dose escalation in the Phase 1 Trial of INB-100 in leukemia patients and will present clinical data at the upcoming ASH (Free ASH Whitepaper) Annual Meeting on December 11, 2023. Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. The presentation at ASH (Free ASH Whitepaper) will highlight clinical data updating the efficacy results of INB-100 including complete responses (CRs) and durability.

Initiated enrollment for the company-sponsored Phase 2 trial of INB-400 in GBM. The Phase 2 clinical trial of INB-400 (NCT05664243), a genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in "Arm A" of the study, in which autologous gamma delta cells will be used to treat patients with newly diagnosed GBM. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients. The company will present a poster at the SNO Annual Meeting.

Hosted R&D Day on October 12, 2023, highlighting IN8bio’s unique Gamma-Delta T cell platform. The event offered the opportunity to gain Key Opinion Leader (KOL) insights into IN8bio’s clinical programs. Featured presentations included those from IN8bio’s management team on gamma-delta T cells, IN8bio’s manufacturing capabilities, an overview of the INB-100, INB-200, and INB-400 clinical programs, as well as presentations from key oncology thought leaders Leo Luznik, M.D., Professor of Oncology at Johns Hopkins Medicine and Michael Bishop, M.D., Director of the David and Etta Jones Center for Cellular Therapy at the University of Chicago, featuring the topics of allogeneic transplantation and the challenges of leukemic relapse. A replay of the webcast event can be found here.

Upcoming Pipeline Milestones and Events

INB-100: Presenting updated Phase 1 trial clinical data from patients with hematological malignancies undergoing HSCT at the ASH (Free ASH Whitepaper) Annual Meeting on December 11, 2023.
INB-200: Complete enrollment of Cohort 3 in the Phase 1 trial; will present updated data at SNO on November 17, 2023 with longer-term follow-up at medical meetings throughout 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at a medical meeting in first half of 2024.
INB-400: Present a poster at the SNO Annual Meeting on November 17, 2023; file investigational new drug (IND) application for allogeneic arms (Arms B and C) of the Phase 2 trial in newly diagnosed and relapsed GBM in 2024.

Third Quarter 2023 Financial Highlights

Research and Development expenses: Research and development expenses were $3.8 million for the three months ended September 30, 2023, compared to $4.3 million for the comparable prior year period. The decrease was primarily due to a reduction in contract research organization expenses for INB-400 related to the IND filing in the prior year period, partially offset by increased personnel-related costs, including salaries, benefits, and non-cash stock-based compensation due to increased headcount.

General and administrative expenses: General and administrative expenses were $3.4 million for the three months ended September 30, 2023, compared to $3.1 million for the comparable prior year period. The increase was primarily due to an increase in professional services.

Net Loss: The Company reported a net loss of $7.2 million, or $0.23 per basic and diluted common share, for the three months ended September 30, 2023, compared to $7.4 million, or $0.34 per basic and diluted common share, for the comparable prior year period.

Cash: As of September 30, 2023, the Company had cash of $12.9 million, compared to $17.0 million as of June 30, 2023.