- Completed dose escalation in Phase 1 Trial of INB-100 with updated clinical data to be presented at the
American Society of Hematology (ASH) Annual Meeting onDecember 11, 2023 (Abstract Number: 4853). Held Research & Development Day , featuring Leo Luznik, M.D. fromJohns Hopkins University andMichael Bishop , M.D. fromThe University of Chicago , highlighting IN8bio’s differentiated clinical and scientific programs and multiple upcoming clinical catalysts.- Presented positive updated biologic correlative data on INB-200 in glioblastoma (GBM) and preclinical data on INB-500 featuring induced pluripotent stem cell (iPSC) derived gamma-delta T cells at the
Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting. - Initiated enrollment for Phase 2 trial of INB-400 in newly diagnosed GBM (NCT05664243).
- Updated Phase 1 clinical data from INB-200 to be presented at
Society for Neuro-Oncology (SNO ) onNovember 17, 2023 .
“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
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. 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 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 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 andThe 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 atJohns Hopkins Medicine andMichael Bishop , M.D., Director of the David andEtta Jones Center for Cellular Therapy at theUniversity 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 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 endedSeptember 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 endedSeptember 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 endedSeptember 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 ofJune 30, 2023 .
About
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 development and continued progress and success of our preclinical studies and clinical trials and programs and product candidates; the timing of initiation, progress (including as to enrollment) and scope of clinical trials, including for INB-100, INB-200 and INB-400; the success of gamma delta T cells as a treatment option for patients with both solid and hematological cancers; the timing of filing of an IND application for INB-400; and IN8bio’s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and to develop new preclinical programs.
CONDENSED BALANCE SHEETS | |||||||
(In thousands, except share and per share data) | |||||||
2023 | |||||||
(unaudited) | 2022 | ||||||
Assets | |||||||
Current assets | |||||||
Cash | $ | 12,854 | $ | 18,182 | |||
Prepaid expenses and other current assets | 3,695 | 4,052 | |||||
Total Current Assets | 16,549 | 22,234 | |||||
Non-current assets | |||||||
Property and equipment, net | 3,738 | 4,397 | |||||
Construction in progress | 145 | 29 | |||||
Restricted cash | 254 | 252 | |||||
Right-of-use assets - finance leases | 1,579 | 1,691 | |||||
Right-of-use assets - operating leases | 3,688 | 4,181 | |||||
Other non-current assets | 255 | 255 | |||||
Total Non-Current Assets | 9,659 | 10,805 | |||||
Total Assets | $ | 26,208 | $ | 33,039 | |||
Liabilities and Stockholders' Equity | |||||||
Liabilities | |||||||
Current liabilities | |||||||
Accounts payable | $ | 748 | $ | 2,091 | |||
Accrued expenses and other current liabilities | 2,440 | 2,342 | |||||
Short-term finance lease liability | 715 | 682 | |||||
Short-term operating lease liability | 783 | 707 | |||||
Total Current Liabilities | 4,686 | 5,822 | |||||
Long-term finance lease liability | 695 | 811 | |||||
Long-term operating lease liability | 3,069 | 3,674 | |||||
Total Non-Current Liabilities | 3,764 | 4,485 | |||||
Total Liabilities | 8,450 | 10,307 | |||||
Stockholders' Equity | |||||||
Preferred stock, par value | — | — | |||||
Common stock, par value | 4 | 3 | |||||
Additional paid-in capital | 101,375 | 83,941 | |||||
Accumulated deficit | (83,621 | ) | (61,212 | ) | |||
Total Stockholders' Equity | 17,758 | 22,732 | |||||
Total Liabilities and Stockholders' Equity | $ | 26,208 | $ | 33,039 |
CONDENSED STATEMENTS OF OPERATIONS | |||||||||||||||
(In thousands, except share and per share data) | |||||||||||||||
(Unaudited) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 3,786 | $ | 4,255 | $ | 12,305 | $ | 10,140 | |||||||
General and administrative | 3,383 | 3,144 | 10,434 | 10,583 | |||||||||||
Total operating expenses | 7,169 | 7,399 | 22,739 | 20,723 | |||||||||||
Other income | — | — | 330 | — | |||||||||||
Loss from operations | (7,169 | ) | (7,399 | ) | (22,409 | ) | (20,723 | ) | |||||||
Net loss | $ | (7,169 | ) | $ | (7,399 | ) | $ | (22,409 | ) | $ | (20,723 | ) | |||
Net loss per share – basic and diluted | $ | (0.23 | ) | $ | (0.34 | ) | $ | (0.79 | ) | $ | (1.05 | ) | |||
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 31,545,783 | 21,661,544 | 28,275,193 | 19,774,070 |
Company Contact:
+ 1 646.600.6GDT (6438)
info@IN8bio.com
Investors & Media
IN8bio@argotpartners.com
Source:
2023 GlobeNewswire, Inc., source