IN8bio Reports Fourth Quarter and Full-Year 2022 Financial Results and Provides Corporate Update

Rhea-AI Summary

IN8bio, Inc. (Nasdaq: INAB) reported strong progress in its gamma-delta T cell therapies during Q4 2022, showcasing significant clinical results. All Cohort 1 leukemia patients maintained durable complete responses, lasting 18 months to 2.7 years in the INB-100 trial. The INB-200 trial demonstrated favorable responses, with patients showing progression-free survival exceeding 1.5 years. The next-generation gamma-delta T cell therapy program, INB-300, presented promising proof-of-concept data. Financially, R&D expenses rose to $14.1 million, and a net loss of $28.5 million was recorded, with cash reserves at $18.2 million as of December 31, 2022.

Positive

• Cohort 1 leukemia patients sustained complete responses for up to 2.7 years.
• Favorable durability observed in INB-200 with patients progression-free beyond 1.5 years.
• Positive proof-of-concept results for INB-300 highlighting its potential.

Negative

• R&D expenses increased significantly, totaling $14.1 million for 2022, up from $7.3 million.
• Net loss for full year 2022 was $28.5 million, worsening from a loss of $14.7 million in 2021.
• Cash position decreased to $18.2 million from $37.0 million year-over-year.

• All Cohort 1 leukemia patients have maintained durable morphological complete responses (CR) beyond 18 months and up to 2.7 years in an ongoing Phase 1 trial of INB-100 as of December 9, 2022; Updated clinical data to be reported at the EBMT Annual Meeting in April 2023
  
• INB-200 continued to show durable and favorable responses, with ongoing patients extending beyond 1.5 years and 1.2 years progression free through year-end 2022; currently enrolling patients in Cohort 3; Updated clinical data expected in mid-2023
  
• Presented positive proof-of-concept data demonstrating the potential of INB-300, a next-generation gamma-delta T cell CAR technology, to target tumors while sparing healthy tissue; Additional updates to this program to be reported at the AACR Annual Meeting in April 2023
  

NEW YORK, March 30, 2023 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies, today announced financial results and operational highlights for the fourth quarter and full-year ended December 31, 2022. In addition, the Company provided an overview of recent corporate developments.

“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

• 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.
  
• 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.
  
• Presented new data at the American Society of Hematology (ASH) 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.
  
• 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

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

• 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 (i) contract research organization expenses related to the INB-400 program and IND, (ii) increased third-party clinical trial and IND-related activities, (iii) increased facility-related costs from opening our new laboratory space in Birmingham, Alabama and (iv) increased personnel-related costs, including salaries, benefits, and stock-based compensation due to increased headcount.
• 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.
• 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.
• 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.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio plans to initiate INB-400, a company-sponsored Phase 2 clinical trial in newly diagnosed glioblastoma following IND clearance in late 2022. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.

Forward Looking Statements

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential of IN8Bio’s DeltEx platform to develop cell therapies to effectively identify and eradicate tumor cells; future results in clinical data relating to the INB-100, 1NB-200 and INB-300 studies or the nsCAR platform; the nsCAR platform’s potential to distinguish between tumor cells and healthy tissue; the timing, initiation, and readout of clinical data from IN8bio’s clinical trials, including expectations regarding enrollment and the timing of data therefrom; INB-300’s ability to improve upon existing technologies; IN8bio’s ability to evaluate nsCAR programs in additional promising targets such as CD3 for AML; the potential of INB-100 to achieve long-lasting durable responses in patients with high-risk or relapsed hematologic malignancies; IN8Bio’s ability to identify potential clinical sites to participate in the multi-center Phase 2 clinical trial for INB-400; IN8bio’s ability to achieve planned milestones, including data readouts from its trials; and the ability of IN8Bio to develop new preclinical programs. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic as well as rising inflation and regulatory developments; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 10, 2022, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Company Contact:
IN8bio, Inc.
Patrick McCall
+ 1 646.600.6GDT (6438)
info@IN8bio.com

Investors & Media Contact:
Argot Partners
IN8bio@argotpartners.com

FAQ

What are the latest results for INB-100 from IN8bio as of March 2023?

As of March 2023, all Cohort 1 leukemia patients treated with INB-100 have maintained durable complete responses, lasting between 18 months and up to 2.7 years.

How is the INB-200 trial progressing for glioblastoma patients?

The INB-200 trial continues to show favorable responses, with some patients remaining progression-free for over 1.5 years as of year-end 2022.

What financial challenges did IN8bio face in 2022?

IN8bio reported a net loss of $28.5 million for the full year 2022, compared to a loss of $14.7 million in 2021, alongside increased R&D expenses.

What updates can be expected from IN8bio's clinical trials in 2023?

IN8bio is set to present updated data for INB-100 and INB-200, and additional preclinical data for INB-300 at various medical meetings throughout 2023.

What is IN8bio's current cash position as of December 31, 2022?

IN8bio's cash position stood at $18.2 million as of December 31, 2022, a decrease from $37.0 million the previous year.