ADDED
As o f March 26, 2026, the registrant had 2,540,518 shares o f common stock, $0.0001 par value, outstanding.
On February 19, 2026, we effected a 1-for-25 reverse stock split of our common stock (the Reverse Stock Split ).
All historical share and per share amounts reflected throughout this Annual Report on Form 10-K have been adjusted to reflect the Reverse Stock Split.
The challenge with IT treatment approaches is that a tumor s stromal, high-fat, dense, poorly vascularized, and pressurized microenvironment is incompatible with and does not absorb water-based products.
We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which have involved injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment.
The problem of the incompatibility of the tumor s environment is independent of any water-based drug s mechanism or approach, i.e.
We believe we have created a product candidate with the necessary chemistry to overcome this local delivery challenge within the tumor.
Data from a cohort of only sarcoma patients whose cancer continued to progress following 3 prior therapies showed a median overall survival of 21.3 months.
Typical median survival for these severe sarcomas is 7.6 to 9.7 months.
The key endpoints of the INVINCIBLE 2 Study were to understand the percentage of necrosis that can be achieved in tumors of varying sizes for a given dose, especially for tumors larger than 2 centimeters in longest diameter.
REMOVED
As o f March 12, 2025, the registrant had 15,180,945 shares o f common stock, $0.0001 par value, outstanding.
The challenge with IT treatment approaches is that a tumor s lipophilic, high fat, dense and pressurized microenvironment is incompatible with and does not absorb water-based products.
We believe that this drug delivery challenge limits the effectiveness of prior and current IT treatments, which involve injecting aqueous drugs into a tumor without sufficient consideration of the tumor environment (regardless of the drug s mechanism or approach, i.e.
We believe we have created a product candidate with the necessary chemistry to overcome this local delivery challenge.
We also sought to determine whether a local or whole-body anti-cancer immune response could be induced.
The trial is enrolling patients and is being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain.
We plan to enroll 333 patients and expect to complete enrollment in the first half of 2026, with an endpoint of overall survival.
We plan to enroll 54 patients and expect to complete enrollment by the end of the first quarter of 2026, and the endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone.
Our current pipeline consists of: INVINCIBLE-3 Study , a Phase 3 open-label, randomized study testing the superiority INT230-6 used as monotherapy compared to the standard of care drugs in 2nd and 3rd line treatment for certain soft tissue sarcoma subtypes.
INVINCIBLE-4 Study , a two cohort Phase 2 randomized, controlled study testing INT230-6 in combination with the SOC treatment (chemotherapy/immunotherapy) (cohort A) and the SOC alone (cohort B) in women in presurgical (neoadjuvant) TNBC.