Instil Bio (TIL) Company Report

IntraBio announced positive top-line results from its pivotal Phase 3 clinical trial (IB1001-303) for N-Acetyl-L-Leucine (IB1001) in treating Ataxia-Telangiectasia (A-T) in children and adults.
The trial achieved statistically significant and clinically meaningful improvements in the primary endpoint, with N-Acetyl-L-Leucine showing a -1.88 point improvement in the SARA score compared to placebo after 12 weeks (p<0.001).
Key secondary endpoints, including ICARS and CGI-I, also demonstrated statistically significant and clinically meaningful improvements.
N-Acetyl-L-Leucine exhibited a favorable safety and tolerability profile, consistent with previous findings, with no serious drug-related adverse events reported.
Following these results, IntraBio plans to initiate regulatory submissions to the FDA, EMA, and other global regulatory authorities for approval of N-Acetyl-L-Leucine for A-T.

Jan 21, 2026, 10:57 PM

IntraBio announces positive Phase III results for Levacetylleucin in Ataxia-Telangiectasia

TIL

Product Launch

IntraBio Inc. announced positive topline results from its Phase III clinical study IB1001-303 for Levacetylleucin in treating Ataxia-Telangiectasia (A-T).
The study met its primary endpoint, demonstrating a statistically significant and clinically relevant improvement of -1.88 points on the SARA scale compared to placebo after 12 weeks of treatment.
Levacetylleucin was found to be safe and well-tolerated, with no drug-related serious adverse events.
IntraBio plans to immediately submit regulatory applications to the US FDA, European Medicines Agency (EMA), and other global authorities for Levacetylleucin for A-T, a neurodegenerative disease currently without approved treatments.

Jan 21, 2026, 10:57 PM

Instil Bio Reports Third Quarter 2025 Financial Results

TIL

Earnings

Guidance Update

New Projects/Investments

Instil Bio reported $83.4 million in cash, cash equivalents, restricted cash, marketable securities, and long-term investments as of September 30, 2025, which is expected to fund its operating plan beyond 2026.
The company's net loss per share for the third quarter ended September 30, 2025, was $2.01, compared to $3.54 for the same period in 2024.
In October 2025, Instil's subsidiary, Axion Bio, dosed the first patient in its Phase 1 clinical trial evaluating AXN-2510/IMM2510 monotherapy in adult patients with advanced solid tumors.
Research and development expenses increased to $9.1 million for the three months ended September 30, 2025, from $0.6 million in the prior year period, while general and administrative expenses decreased to $5.9 million from $10.7 million over the same periods.

Nov 13, 2025, 12:05 PM

Instil Bio Reports Third Quarter 2025 Financial Results and Provides Corporate Update

TIL

Earnings

Guidance Update

New Projects/Investments

Instil Bio reported its third quarter 2025 financial results and provided a corporate update on November 13, 2025.
As of September 30, 2025, Instil had $83.4 million in cash, cash equivalents, restricted cash, marketable securities, and long-term investments, which is expected to fund its operating plan beyond 2026.
The company reported a net loss per share of $2.01 for the three months ended September 30, 2025, compared to $3.54 for the same period in 2024.
In October, Instil's subsidiary, Axion Bio, dosed the first patient in its Phase 1 clinical trial of ‘2510 as monotherapy in patients with relapsed or refractory solid tumors.

Nov 13, 2025, 12:00 PM

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Instil Bio (TIL)