- Presented updated glioblastoma (“GBM”) data demonstrating durable survival and a favorable safety profile across Phase 1 and Phase 2 programs, with repeat dosing of DeltEx™ Drug-Resistant Immunotherapy ?d T cells (“DRI”) nearly doubling median progression-free survival (“mPFS”) to 13.0 months versus 6.6 months in a contemporaneous standard-of-care control cohort (+97%)
- Closed initial
$20.1 million tranche of a private placement of up to$40.2 million in gross proceeds; net proceeds extend cash runway into the first half of 2027 and support advancement of the gamma-delta T cell engager (“TCE”) platform
- Continued advancement of gamma-delta T cell therapies and TCE pipeline across oncology and autoimmune diseases with multiple milestones expected in 2026
“In 2025, we delivered meaningful progress financially and across our clinical ?d T cell therapy programs and our next-generation T cell engager platform,” said
Key Highlights
Strengthened Balance Sheet with up to
In
- Financing led by
Coastlands Capital , with participation from new and existing investors.
- Net proceeds of
$18.5 million expected to extend the Company’s cash runway into the first half of 2027.
- Proceeds intended to support IND-enabling studies for INB-619 ?d TCE, further discussions with the FDA on potential clinical pathways for the GBM program, continued advancement of the Company’s ?d T cell therapy programs, and general corporate purposes.
Presented Updated Clinical Data Demonstrating Durable Survival Improvements in Newly Diagnosed Glioblastoma
In
- mPFS for repeat dose DeltEx DRI patients was 13.0 months vs. 6.6 months for SOC control cohort (+97% improvement).
- Median overall survival (“mOS”) in repeat dose patients had not yet been reached at 17.2+ months, surpassing the 13.2-month final mOS for SOC control arm.
- Several patients remained progression-free beyond two years, and one grade 4 glioma patient remains progression-free for greater than 4.5 years, highlighting the long-term benefit of INB-200.
- No dose-limiting toxicities (“DLTs”), cytokine release syndrome (“CRS”), neurotoxicity (“ICANS”), tumor inflammation-associated neurotoxicity (“TIAN”) or other unexpected severe adverse events were observed.
- Results reinforce the potential of repeat-dose ?d T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma and support continued regulatory engagement regarding potential clinical pathways.
Continued Advancing Next-Generation Gamma-Delta T Cell Engager Platform
- Continued advancing INB-600 platform, featuring novel ?d T cell engagers designed to potentially improve durability and safety compared with traditional CD3-targeting engagers.
- Progressing INB-619, a CD19-targeting ?d T cell engager for potential use in oncology and autoimmune diseases into IND-enabling studies with initial animal data expected in 2026.
- Presented encouraging preclinical data including complete B-cell depletion, robust ?d T cell expansion, and minimal CRS-associated cytokine release at The
American College of Rheumatology (“ACR”) Convergence 2025 meeting, supporting differentiation of the platform.
Leadership Update
In
Anticipated Milestones
- Guidance from the FDA on potential regulatory pathway by the second half of 2026
- Additional clinical updates on our GBM programs, including final mOS data from the total data set, at medical meetings in mid- and late-2026
- Initial preclinical animal data and additional IND-enabling data for INB-619 expected in the second half of 2026
- Completion of patient dosing in INB-100 in early 2026 and report long-term follow-up results at a medical meeting in late 2026
Fourth Quarter and Full Year 2025 Financial Highlights
- Cash position: As of
December 31, 2025 , the Company had cash of$27.1 million , compared with$11.1 million as ofDecember 31, 2024 .
- Research and Development (R&D) expenses: R&D expenses were
$2.6 million for the three months endedDecember 31, 2025 , compared with$3.6 million for the comparable prior year period. R&D expenses were$10.2 million for the year endedDecember 31, 2025 , compared with$17.0 million in the prior year. Non-cash stock-based compensation expense included in R&D expense was$1.2 million for the full year 2025 and$0.3 million for the fourth quarter of 2025.
- General and administrative (G&A) expenses: G&A expenses were
$2.4 million for the three months endedDecember 31, 2025 , compared with$2.6 million for the comparable prior year period. G&A expenses were$9.7 million for the year endedDecember 31, 2025 , compared with$12.6 million in the prior year. Non-cash stock-based compensation expense included in G&A expense was$2.0 million for the full year 2025 and$0.4 million for the fourth quarter of 2025.
- Severance and related charges: Severance and related charges were nil for the year ended
December 31, 2025 , compared with$1.1 million in the prior year.
- Net loss: The Company reported a net loss of
$4.9 million , or$0.45 per basic and diluted common share, for the three months endedDecember 31, 2025 , compared with a net loss of$6.2 million , or$2.38 per basic and diluted common share, for the comparable prior year period. For the year endedDecember 31, 2025 , net loss was$19.4 million , or$4.44 per basic and diluted common share, compared with a net loss of$30.4 million , or$17.05 per basic and diluted common share, for the prior year.
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 therapeutic potential of IN8bio’s product candidates; the potential of repeat-dose ?d T cell therapy to meaningfully improve outcomes in newly diagnosed glioblastoma; the potential of IN8bio’s INB-600 platform to improve durability and safety compared with traditional CD3-targeting engagers; IN8bio’s ability to achieve anticipated milestones, including receipt of guidance from the FDA on regulatory pathways, expected presentations and data readouts from its preclinical studies and clinical trials, patient dosing timelines and advancement of clinical development plans; the milestone-driven closing of the private placement and the use of proceeds from the private placement; IN8bio’s cash runway; and other statements that are not historical fact.
BALANCE SHEETS (In thousands, except share and per share data) | ||||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash | $ | 27,092 | $ | 11,120 | ||||
| Prepaid expenses and other current assets | 788 | 1,458 | ||||||
| Total Current Assets | 27,880 | 12,578 | ||||||
| Non-current assets | ||||||||
| Property and equipment, net | 1,858 | 2,858 | ||||||
| Restricted cash | 220 | 266 | ||||||
| Right-of-use assets – finance leases | 296 | 1,068 | ||||||
| Right-of-use assets – operating leases | 1,882 | 3,899 | ||||||
| Other non-current assets | 146 | 275 | ||||||
| Total Non-Current Assets | 4,402 | 8,366 | ||||||
| Total Assets | $ | 32,282 | $ | 20,944 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Liabilities | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 309 | $ | 389 | ||||
| Accrued expenses and other current liabilities | 1,633 | 1,047 | ||||||
| Short-term finance lease liability | 295 | 694 | ||||||
| Short-term operating lease liability | 924 | 953 | ||||||
| Total Current Liabilities | 3,161 | 3,083 | ||||||
| Long-term finance lease liability | — | 295 | ||||||
| Long-term operating lease liability | 1,563 | 3,088 | ||||||
| Total Non-Current Liabilities | 1,563 | 3,383 | ||||||
| Total Liabilities | 4,724 | 6,466 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity | ||||||||
| Preferred stock, par value | — | — | ||||||
| Common stock, par value | 10 | 7 | ||||||
| Additional paid-in capital | 168,644 | 136,127 | ||||||
| Accumulated deficit | (141,096 | ) | (121,656 | ) | ||||
| Total Stockholders' Equity | 27,558 | 14,478 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 32,282 | $ | 20,944 | ||||
(1) All share amounts and per share amounts disclosed above have been restated to reflect a one-for-thirty reverse stock split effected in | ||||||||
STATEMENTS OF OPERATIONS (In thousands, except share and per share data) | ||||||||
| Year Ended | ||||||||
| 2025 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 10,211 | $ | 16,962 | ||||
| General and administrative | 9,650 | 12,637 | ||||||
| Severance and related charges | — | 1,068 | ||||||
| Total operating expenses | 19,861 | 30,667 | ||||||
| Interest income | 421 | 230 | ||||||
| Loss from operations | (19,440 | ) | (30,437 | ) | ||||
| Net loss | $ | (19,440 | ) | $ | (30,437 | ) | ||
| Net loss per share –?basic and diluted | $ | (4.44 | ) | $ | (17.05 | ) | ||
| Weighted-average number of shares used in computing net loss per common share, basic and diluted(1) | 4,374,328 | 1,784,890 | ||||||
(1) All share amounts and per share amounts disclosed above have been restated to reflect a one-for-thirty reverse stock split effected in | ||||||||
Investors & Company Contacts:
646.933.5603
pfmccall@IN8bio.com
Media Contact
917.291.5744
kimberly.ha@kkhadvisors.com
Source: 