On November 10, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company discovering and developing innovative gamma-delta T cell therapies that utilize its DeltEx platform, reported financial results, corporate developments, and operational highlights for the third quarter ended September 30, 2022 (Press release, In8bio, NOV 10, 2022, View Source [SID1234623664]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We achieved several important corporate goals during the third quarter that had been the focus of our team’s energy for much of 2022. Securing the partnership with the Dunbar CAR T-Cell Program at the University of Louisville provides us with access to a high-quality good manufacturing practice (GMP) facility and is a significant step towards advancing our INB-400 program into Phase 2 clinical trials. There has been significant industry interest in gamma-delta T cells in 2022, and the recruitment of Dr. LaMontagne, with his extensive experience in pharma and cellular therapy, marks the initiation of our business development activities. With the introduction of induced pluripotent stem cells (iPSCs) to our DeltEx platform, we possess a comprehensive suite of technologies and capabilities to target cancer with gamma-delta T cells," stated William Ho, CEO and co-founder of IN8bio. "We are excited about the consistency of the data we have been generating across our clinical pipeline and look forward to providing clinical updates at the ASH (Free ASH Whitepaper) Annual Meeting in December and early next year. Our team is focused on advancing innovative therapies for cancer and continuing to execute on key milestones in the months to come."
Business Highlights & Clinical Updates
Provided update from the ongoing Phase 1 clinical trial of INB-100 in patients with leukemia who are undergoing haploidentical stem cell transplantation. All three high-risk AML patients from the first cohort continued to demonstrate durable morphologic CR and remained progression-free and alive for more than one year. Two of the three patients remain in morphologic CR for more than two
years. The safety profile continues to be manageable with no dose-limiting toxicities (DLTs). IN8bio plans to present additional data for INB-100 at the upcoming 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to take place December 10-13 in New Orleans, Louisiana.
Raised $9.8 million of net proceeds in an underwritten offering of 5,663,686 shares of common stock to fund IN8bio’s clinical development program and general operating activities.
Strengthened management team with the addition of Kenneth R. LaMontagne, Ph.D., as Senior Vice President, Business Development.
Broadened intellectual property coverage for DeltEx platform with the issuance of a new European patent.
Expanded the intellectual property estate of the DeltEx platform with the issuance of a new patent in Europe covering any genetic modification conveying chemotherapy resistance to immune cell types, including gamma-delta T cells and natural killer (NK) cells.
Appointed Michael R. Bishop, M.D., Director, Hematopoietic Cellular Therapy Program, Director of the David and Etta Jonas Center for Cellular Therapy, and Professor of Medicine at the University of Chicago, to IN8bio’s Scientific Advisory Board. Dr. Bishop is globally recognized for his extensive research and expertise in the prevention and treatment of relapse of lymphomas following stem cell transplantation.
Announced a partnership with the Dunbar CAR T-Cell Program at the University of Louisville as the manufacturing center for INB-400.
The Company filed its IND for INB-400 in November 2022 and is actively identifying potential clinical sites to participate in the multi-center Phase 2 clinical trial, subject to receiving clearance from the FDA for the IND.
Third Quarter 2022 Financial Results
Cash position: As of September 30, 2022, the Company had cash of $27.6 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.
Research and Development (R&D) expenses: R&D expenses were $4.3 million for the three months ended September 30, 2022, compared to $1.4 million for the comparable prior year period. The increase in R&D expenses were primarily due to (i) contract research organization expenses related to INB-400, (ii) increased third-party clinical trial and IND-related activities, and (iii) increased personnel-related costs, including salaries, benefits, and stock-based compensation due to increased headcount.
General and administrative expenses: General and administrative expenses were $3.1 million for the three months ended September 30, 2022, compared to $2.0 million for the comparable prior year period. The increase was primarily due to increased personnel-related costs, including salaries, benefits, and stock-based compensation reflecting an increased headcount, expenses related to the Company’s follow-on underwritten public offering, insurance costs, and expenses associated with operating as a public company.
Net loss: The Company reported a net loss attributable to common stockholders of $7.4 million, or $0.34 per basic and diluted common share, for the three months ended September 30, 2022, compared to a net loss attributable to common stockholders of $3.4 million, or $0.25 per basic and diluted common share, for the comparable prior year period.