IN8bio Reports Third Quarter 2025 Financial Results and Recent Business Highlights

Rhea-AI Summary

IN8bio (Nasdaq: INAB) reported Q3 2025 results and program updates on Nov 6, 2025. The company presented new preclinical data on INB-619 showing CD19-targeted γδ T cell engager potency comparable to FDA-approved CD19/CD20 engagers with minimal cytokine release, and advanced its γδ T cell platform.

IN8bio expanded the Phase 1 INB-100 trial to The Ohio State University to accelerate enrollment and plans updated INB-200/400 GBM data at SNO (Nov 19-23, 2025) and additional INB-619 preclinical data at ASH (Dec 6-9, 2025).

Q3 financials: R&D $2.1M, G&A $1.9M, net loss $3.9M (‑$0.85/share), and cash $10.7M as of Sep 30, 2025.

Positive

• INB-619 preclinical showed B cell elimination equivalent to approved engagers
• R&D expense fell to $2.1M in Q3 2025 from $3.3M in Q3 2024
• G&A expense fell to $1.9M in Q3 2025 from $2.7M in Q3 2024
• Net loss improved to $3.9M in Q3 2025 from $7.1M in Q3 2024
• Cash balance increased to $10.7M as of Sep 30, 2025
• Expanded INB-100 Phase 1 to The Ohio State University to speed enrollment

Negative

• Company reported an ongoing quarterly net loss of $3.9M in Q3 2025
• R&D decline driven partly by a prior strategic pause on the INB-400 program

Insights

Clinical Immunology Expert

Preclinical CD19 γδ TCE data look promising for potency and cytokine-sparing; clinical relevance remains early.

INB-619 demonstrated equivalent B cell elimination to approved CD19/CD20 engagers in donor SLE models while showing minimal cytokine release, suggesting a distinct mechanism of targeted γδ T cell activation that could reduce acute immune toxicity seen with CD3-directed engagers.

These results are preclinical and do not prove clinical safety or efficacy; translation to patients often changes potency and cytokine profiles. Key near-term readouts to watch are the INB-619 presentations at December 6-9, 2025 (ASH) and any first-in-human data that report on cytokine release and depth/duration of B cell depletion within the first 1–3 months after dosing.

Financial and Programmatic Analyst

Operational execution shows cost reduction and program focus, but cash runway is limited.

R&D and G&A expense declines reduced quarterly net loss to $3.9 million, and cash rose to $10.7 million as of September 30, 2025, reflecting tighter spending and prioritization after the September 2024 pipeline refocus.

The company lists imminent data presentations (SNO Nov 19-23, 2025; ASH Dec 6-9, 2025) and a Phase 1 expansion site at OSU that may accelerate enrollment; these are concrete near-term catalysts over the next 1–3 months. Monitor cash burn versus milestones and any financing notices because available cash implies a finite runway absent additional funding.

• Presented new preclinical data on INB-619, a novel gamma-delta (γδ) T cell engager (TCE), demonstrating equivalent potency comparable to FDA-approved commercial products with minimal adverse cytokine release, highlighting its potential to achieve deep B cell depletion with an improved safety profile
• Expanded Phase 1 INB-100 trial to The James Comprehensive Cancer Center at The Ohio State University, supporting faster enrollment to complete the Phase 1 expansion cohort
• Continued to advance IN8bio’s proprietary γδ T cell platform with ongoing pipeline progression and updated INB-200/400 clinical data in newly diagnosed glioblastoma (GBM) to be presented at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting
  

NEW YORK, Nov. 06, 2025 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, today reported financial results and business highlights for the third quarter ended September 30, 2025.

Key Highlights:

Presented New Preclinical Data on INB-619 at ACR Convergence 2025

• IN8bio presented compelling new preclinical data on INB-619, its CD19 targeting γδ TCE, at the 2025 American College of Rheumatology (ACR) Convergence Meeting. In preclinical systemic lupus erythematosus (SLE) donor models, INB-619 achieved complete elimination of B cells with efficacy equivalent to commercial CD19 and CD20 engagers, including the FDA-approved compounds blinatumomab and mosunetuzumab.
• The data showed that INB-619’s selective γδ T cell activation drives deep B cell depletion with minimal cytokine release, confirming the potential for improved safety over conventional CD3-directed engagers in development.
• INB-619’s targeted immune activation and cytokine-sparing design could allow for higher doses, deeper B cell depletion and immune reset that has not been observed with other protein engagers to date.
  

Expanded INB-100 Clinical Trial to Multiple Sites

• IN8bio expanded the Phase 1 trial of INB-100 to include The Ohio State University (OSU), diversifying centers and accelerating patient enrollment.
• The addition of Sarah A. Wall, M.D., the Director of Clinical Operations for the Transplant and Cell Therapy Program and an expert in elderly patients with leukemias from this leading academic institution, underscores the strong clinical interest in advancing INB-100, a donor-derived, allogeneic γδ T cell therapy in patients with leukemias undergoing haploidentical stem cell transplantation.

William Ho, CEO and co-founder of IN8bio, commented, “During the quarter, we continued to execute on our goal of developing next-generation γδ T cell therapies. Our focus on the novel biology of γδ T cells underscores our advancements along with the strength and versatility of our DeltEx™ platform. This quarter, we expanded our INB-100 clinical operations to additional sites to accelerate enrollment, and we reported compelling preclinical data at the 2025 ACR Convergence Meeting. Our INB-619 program is a novel and differentiated program in a sea of CD3-based TCE’s that have yet to achieve immune reset in the autoimmune disease setting. We remain focused on delivering the next generation of γδ T cell therapies designed to redefine immune modulation and improve patient outcomes.”

Upcoming Anticipated Pipeline Milestones and Events

• Updated Phase 1 and 2 data from the INB-200/400 program in newly diagnosed GBM to be presented at the SNO Annual Meeting, November 19-23, 2025
• Additional preclinical data from INB-619 γδ T cell engager program in oncology will be presented at the American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025

Third Quarter 2025 Financial Highlights

• Research and Development (R&D) expenses: R&D expenses were $2.1 million for the three months ended September 30, 2025, compared with $3.3 million for the comparable prior year period. This amount includes non-cash items such as stock-based compensation (SBC) and depreciation of $0.5 million for the three months ended September 30, 2025. The change was primarily due to a strategic pause on clinical trial-related activities for the INB-400 program last year and personnel-related costs, which followed the Company’s pipeline prioritization announcement in September 2024. The Company continues to prioritize programs demonstrating the strongest clinical signal and commercial opportunity.
• General and administrative (G&A) expenses: G&A expenses were $1.9 million for the three months ended September 30, 2025, compared with $2.7 million for the comparable prior year period. This amount includes non-cash items such as SBC and depreciation of $0.4 million for the three months ended September 30, 2025. The change was primarily due to cost savings related to personnel-related costs, director and officer insurance premiums and professional services.
• Net loss: The Company reported a net loss of $3.9 million, or $0.85 per basic and diluted common share, for the three months ended September 30, 2025, compared with a net loss of $7.1 million, or $4.49 per basic and diluted common share, for the comparable prior year period.
• Cash position: As of September 30, 2025, the Company had cash of $10.7 million, compared with $4.0 million as of September 30, 2024.

About IN8bio

IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell product candidates for unmet medical needs. γδ T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company's lead program, INB-100, is focused on acute myeloid leukemia, evaluating haplo-matched allogeneic γδ T cells given to patients following a hematopoietic stem cell transplant. The Company is also evaluating autologous DeltEx DRI γδ T cells, in combination with standard of care, for glioblastoma in its INB-200 and 400 programs, and INB-600, advancing novel γδ T cell engagers for potential oncology and autoimmune indications. For more information about IN8bio, 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 to accelerate enrollment of the Phase 1 trial of INB-100; the potential of INB-619 to achieve deep B cell depletion and immune reset with an improved safety profile over conventional CD3-directed engagers in development, including the potential for higher dose levels; IN8bio’s ability to develop gamma-delta T cell therapies that redefine immune modulation and improve patient outcomes; IN8bio’s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials and advancement of clinical development plans; and other statements that are not historical fact. 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; 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 be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of its development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; 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; the uncertainty of 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, which 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 August 7, 2025, 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.

IN8BIO, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and per share data)
		September 30,
		2025				December 31,
		(unaudited)				2024
Assets						(Note 2)
Current assets
Cash		$	10,689			$	11,120
Prepaid expenses and other current assets			1,079				1,458
Total Current Assets			11,768				12,578
Non-current assets
Property and equipment, net			2,103				2,858
Restricted cash			273				266
Right-of-use assets - finance leases			416				1,068
Right-of-use assets - operating leases			2,039				3,899
Other non-current assets			169				275
Total Non-Current Assets			5,000				8,366
Total Assets		$	16,768			$	20,944
Liabilities and Stockholders' Equity
Liabilities
Current liabilities
Accounts payable		$	204			$	389
Accrued expenses and other current liabilities			418				1,047
Short-term finance lease liability			343				694
Short-term operating lease liability			738				953
Total Current Liabilities			1,703				3,083
Long-term finance lease liability			64				295
Long-term operating lease liability			1,812				3,088
Total Non-Current Liabilities			1,876				3,383
Total Liabilities			3,579				6,466
Stockholders' Equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; no shares issued and outstanding			—				—
Common stock, par value $0.0001 per share; 490,000,000 shares authorized at September 30, 2025 and December 31, 2024; 4,589,196 and 2,416,066 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively(1)			10				7
Additional paid-in capital			149,333				136,127
Accumulated deficit			(136,154	)			(121,656	)
Total Stockholders' Equity			13,189				14,478
Total Liabilities and Stockholders' Equity		$	16,768			$	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 June 2025. Refer to the Quarterly Report on Form 10-Q, for details.

IN8BIO, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2025				2024				2025				2024
Operating expenses:
Research and development		$	2,104			$	3,309			$	7,563			$	13,368
General and administrative			1,863				2,732				7,265				10,007
Severance and related charges			—				1,068				—				1,068
Total operating expenses			3,967				7,109				14,828				24,443
Interest income			113				23				330				166
Loss from operations			(3,854	)			(7,086	)			(14,498	)			(24,277	)
Net loss		$	(3,854	)		$	(7,086	)		$	(14,498	)		$	(24,277	)
Net loss per share – basic and diluted		$	(0.85	)		$	(4.49	)		$	(4.18	)		$	(16.02	)
Weighted-average number of shares used in computing net loss per common share, basic and diluted(1)			4,537,683				1,577,363				3,465,257				1,514,959

⁽¹⁾ All share amounts and per share amounts disclosed above have been restated to reflect a one-for-thirty reverse stock split effected in June 2025. Refer to the Quarterly Report on Form 10-Q, for details.

Investors & Company Contacts:

IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com

Media Contact
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com

FAQ

What did IN8bio announce about INB-619 at ACR Convergence 2025?

IN8bio presented preclinical data showing INB-619 achieved deep B cell depletion comparable to FDA-approved CD19/CD20 engagers with minimal cytokine release.

How did IN8bio perform financially in Q3 2025 (INAB)?

For Q3 2025 IN8bio reported R&D $2.1M, G&A $1.9M, net loss $3.9M (‑$0.85/share), and cash $10.7M as of Sep 30, 2025.

What is the significance of IN8bio expanding the INB-100 Phase 1 trial to OSU?

Adding The Ohio State University aims to diversify trial sites and accelerate patient enrollment for the donor-derived allogeneic γδ T cell therapy INB-100.

When will IN8bio present updated INB-200/400 GBM data and additional INB-619 data?

Updated INB-200/400 GBM data will be presented at SNO on Nov 19-23, 2025 and additional INB-619 preclinical data at ASH on Dec 6-9, 2025.

Does IN8bio report clinical efficacy for INB-619 in patients?

No patient clinical efficacy was reported; the announcement describes preclinical models showing comparable potency and reduced cytokine release.