On March 30, 2023 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, reported financial results and operational highlights for the fourth quarter and full-year ended December 31, 2022 (Press release, In8bio, MAR 30, 2023, View Source [SID1234629604]). In addition, the Company provided an overview of recent corporate developments.

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"We are extremely pleased with the outstanding progress IN8bio has made in the past year and the encouraging clinical results we have observed across our gamma-delta T cell platform in both solid and liquid tumors," remarked William Ho, CEO and co-founder of IN8bio. "Our lead clinical programs, INB-100 and INB-200, continue to deliver promising outcomes with longer than expected relapse free and overall survival rates. Last year, we showcased our manufacturing, regulatory and clinical capabilities by filing and receiving clearance for our first corporate-sponsored IND from the FDA for INB-400. Additionally, our team remains committed to leveraging our profound knowledge of gamma-delta T cell biology to drive innovation in next-generation chimeric antigen receptor (CAR) technology. Most recently, we disclosed new preclinical data from our INB-300 platform, demonstrating a CAR construct that can differentiate between tumor and healthy tissue when both express the targeted antigen. We eagerly anticipate releasing additional clinical updates and unveiling our continued progress throughout this year."

Business Highlights and Recent Developments

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Presented initial preclinical data demonstrating how INB-300, the Company’s novel non-signaling gamma-delta CAR-T platform (nsCAR) has the unique ability to distinguish between tumor and healthy tissue. Using the well-established CD-19 target, the proof-of-concept study revealed that INB-300 (ns19CAR) eliminated 80% of the B cell leukemia cell line and only 5% of healthy B cells when both expressed CD19. These results demonstrating the wider therapeutic index support the potential expansion of CAR technology for previously "undruggable" cancer targets in indications including acute myeloid leukemia (AML) and solid tumor cancers.
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Provided a clinical update from the ongoing INB-200 Phase 1 trial in patients with newly diagnosed glioblastoma (GBM), highlighting encouraging progression free survival results. As of December 31, 2022, eight patients with newly diagnosed glioblastoma (GBM) had been dosed with INB-200: three in Cohort 1 (single dose), four in Cohort 2 (three doses) and one in Cohort 3 (six doses). Two Cohort 2 patients died of unrelated causes with no evidence of progression before death, while two other patients in the same cohort remained alive, progression-free and clinically asymptomatic at 1.5 and 1.2 years, respectively.
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Presented new data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating the potential of INB-100 to achieve long-term, durable responses in patients with high-risk or relapsed hematologic malignancies. The findings were based on the ongoing Phase 1 trial of INB-100, a single-dose allogeneic gamma-delta T cell therapy, administered to patients with hematologic malignancies undergoing haploidentical stem cell transplantation (HSCT). All trial participants remained progression-free as of December 9, 2022, with the longest response durations extending beyond 2.7 years.
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Obtained U.S. Food and Drug Administration (FDA) clearance for the Company-sponsored INB-400 Investigational New Drug (IND) application. This will enable the initiation of a Phase 2 clinical trial for INB-400, a genetically modified autologous gamma-delta T cell therapy targeting newly diagnosed GBM. The study will evaluate safety, efficacy, and tolerability at leading medical centers across the United States.

Upcoming Pipeline Milestones and Events

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INB-100: Report updated Phase 1 trial data from leukemia patients undergoing HSCT at the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in April 2023; define recommended Phase 2 dose for INB-100.

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INB-200: Complete enrollment of Cohort 3 in the Phase 1 trial; report updated data and results with longer-term follow-up at medical meetings throughout 2023.

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INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023.

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INB-400: Initiate patient enrollment in the company-sponsored Phase 2 trial of INB-400, a genetically modified autologous gamma-delta T cell therapy, targeting newly diagnosed GBM in the second half of 2023.

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INB-410: Submit a new IND to the FDA for a Phase 1b trial of INB-410, a genetically modified allogeneic gamma-delta T cell therapy in newly diagnosed and relapsed GBM in late 2023.

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New solid tumor indications: Announce and present relevant data at a scientific conference in the first half of 2023.

Fourth Quarter and Full Year 2022 Financial Highlights

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Cash position: As of December 31, 2022, the Company had cash of $18.2 million, compared to $37.0 million as of December 31, 2021. The decrease in cash was primarily due to cash used by the Company in R&D and continued operations to advance its programs along with ongoing construction of a state-of-the-art ~10,000 sq. ft. R&D facility in Birmingham, AL.
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Research & Development (R&D) expenses: R&D expenses were $4.0 million for the three months ended December 31, 2022, compared to $2.7 million for the comparable prior year period. R&D expenses were $14.1 million for the year ended December 31, 2022, compared to $7.3 million in the prior year. The increase in R&D expenses was primarily due to contract research organization expenses related to the INB-400 program and IND, increased third-party clinical trial and IND-related activities, increased facility-related costs from opening our new laboratory space in Birmingham, Alabama and increased personnel-related costs, including salaries, benefits, and stock-based compensation due to increased headcount.
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General and administrative (G&A) expenses: G&A expenses were $3.9 million for the three months ended December 31, 2022, compared to $3.2 million for the comparable prior year period. G&A expenses were $14.5 million for the year ended December 31, 2022, compared to $7.3 million in the prior year. The increase was primarily due to increased personnel-related costs, including salaries, benefits, and stock-based compensation reflecting an increased headcount, facility-related costs, insurance costs, and expenses associated with operating as a public company.
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Net loss: The Company reported a net loss of $7.8 million, or $0.32 per basic and diluted common share, for the three months ended December 31, 2022, compared to a net loss of $5.9 million, or $0.44 per basic and diluted common share, for the comparable prior year period. For the full year, net loss was $28.5 million, or $1.36 per basic and diluted common share, compared to a net loss of $14.7 million, or $1.47 per basic and diluted common share, for the comparable prior year.